Medical Devices

May 2017 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2017


DEVICE: Resultz Lice & Egg Removal Kit
Piedmont Pharmaceuticals, LLC     510(k) NO: K151562(Traditional)
ATTN: Kathleen G. Palma           PHONE NO : 336 5540320 
204 Muirs Chapel Road, Ste 200    SE DECISION MADE: 08-MAY-17
Greensboro NC  27410              510(k) STATEMENT
                                                    

DEVICE: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
3M COMPANY                        510(k) NO: K153410(Traditional)
ATTN: Melissa    Forth            PHONE NO : 651 7375016 
3M CENTER, 2510 CONWAY AVE, BLDG 2SE DECISION MADE: 15-MAY-17
ST.PAUL MN  55144                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife Misty Finity Nebulizer
CareFusion                        510(k) NO: K153748(Traditional)
ATTN: Erika  Fernandez            PHONE NO : 847 3628097 
75 N Fairway Drive                SE DECISION MADE: 17-MAY-17
Vernon Hills IL  60047            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
THAYER MEDICAL CORPORATION        510(k) NO: K160109(Traditional)
ATTN: MEGHAN  MCGOVERN            PHONE NO : 520 7905393 
4575 SOUTH PALO VERDE ROAD SUITE 3SE DECISION MADE: 19-MAY-17
TUCSON AZ  85714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI Compatibility for Existing Zimmer Dental Implant Systems
Zimmer Dental, Inc.               510(k) NO: K160398(Traditional)
ATTN: Alex  Eastes                PHONE NO : 760 9294300 
1900 Aston Ave.                   SE DECISION MADE: 17-MAY-17
Carlsbad CA  92008                510(k) STATEMENT
                                                    

DEVICE: Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube   
COOK INCORPORATED                 510(k) NO: K160509(Traditional)
ATTN: Erum B. Nasir               PHONE NO : 812 3353575 102607
750 DANIELS WAY                   SE DECISION MADE: 18-MAY-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barone Jejunostomy Catheter Set 
COOK INCORPORATED                 510(k) NO: K160567(Traditional)
ATTN: Erum  B. Nasir              PHONE NO : 812 3353575 102607
750 DANIELS WAY                   SE DECISION MADE: 18-MAY-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anybattery C2 Rechargeable Battery
Anybattery, Inc.                  510(k) NO: K160667(Traditional)
ATTN: Ed  Speegle                 PHONE NO : 651 4230555 
2605 160th Street W #16           SE DECISION MADE: 11-MAY-17
Rosemont MN  55068                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICRORUPTOR 6
MERIDIAN AG                       510(k) NO: K160677(Traditional)
ATTN: FRANZISKA  GOTSCHI          PHONE NO : 41 33 3341111 
BIERIGUTSTRASSE 7                 SE DECISION MADE: 19-MAY-17
THUN  CH CH-3608                  510(k) STATEMENT
                                                    

DEVICE: Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
SEMPERIT INVESTMENTS ASIA PTE. LTD510(k) NO: K160781(Abbreviated)
ATTN: CLEMENS  EICHLER            PHONE NO : 65 597 207805 
8 Jurong Town Hall Road #29 - 03 TSE DECISION MADE: 02-MAY-17
SINGAPORE  SG 609434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINISCAV
Sedation Systems LLC              510(k) NO: K160950(Traditional)
ATTN: S. Michael Bender           PHONE NO : 888 9595288 
2471 McMullen Booth Rd, Ste. 316  SE DECISION MADE: 05-MAY-17
Clearwater FL  33759              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
Genea Biomedx Pty Ltd             510(k) NO: K161261(Traditional)
ATTN: Kea  Dent                   PHONE NO : 61 2 84847677 
Level 2, 321 Kent Street          SE DECISION MADE: 12-MAY-17
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Supreme and Response Electrophysiology Catheters
Surgical Instrument Service and Sa510(k) NO: K161272(Traditional)
ATTN: Brandi J. Panteleon         PHONE NO : 541 9233310 
(dba Medline ReNewal) 2747 SW 6th SE DECISION MADE: 18-MAY-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynamika
IMAGE ANALYSIS LIMITED            510(k) NO: K161601(Traditional)
ATTN: Mark   Hinton               PHONE NO : 44 207 6309926 
QABC MINSTER HOUSE, 272-274 VAUXHASE DECISION MADE: 17-MAY-17
London  GB SW1V 1BA               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSTEM Implant System - Abutment
OSSTEM IMPLANT Co., Ltd.          510(k) NO: K161689(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 22-MAY-17
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Silicone Foley Catheter
Teleflex Medical, Inc.            510(k) NO: K161770(Traditional)
ATTN: Lori  Pfohl                 PHONE NO : 919 4918960 
2917 Weck Drive                   SE DECISION MADE: 05-MAY-17
Research Triangle Park NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iGlucose Blood Glucose Monitoring System
BIONIME CORPORATION               510(k) NO: K161790(Traditional)
ATTN: Tino  Lee                   PHONE NO : 886 4 23692388 
NO. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 02-MAY-17
Taichung City  TW 40242           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEAMSCAN
PTW-Freiburg Physikalisch Technisc510(k) NO: K161807(Traditional)
ATTN: Sandor-Csaba  Ats           PHONE NO : 49 761 49055896 
Dr. Pychlau GmbH Loerracher Str. 7SE DECISION MADE: 19-MAY-17
Freiburg  DE 79115                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frova Intubating Introducer
WILLIAM COOK EUROPE APS           510(k) NO: K161813(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 5686 8756 
SANDET 6                          SE DECISION MADE: 19-MAY-17
BJAEVERSKOV  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LATEX EXAMINATION GLOVE POWDER FREE
CAREGLOVE GLOBAL SDN BHD          510(k) NO: K161833(Traditional)
ATTN: LIM KWEE SHYAN              PHONE NO : 60 667 82377 
LOT 17479, LRG SENAWANG 3/2, OFF JSE DECISION MADE: 23-MAY-17
SEREMBAN  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter
XUZHOU YONGKANG ELECTRONIC SCIENCE510(k) NO: K161938(Traditional)
ATTN: YANLI  LI                   PHONE NO : 86 516 87892766 631
4F BUILDING C8, 40 JINGSHAN ROAD, SE DECISION MADE: 08-MAY-17
XUZHOU  CN 102628                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K161950(Traditional)
ATTN: Keshin  Hu                  PHONE NO : 86 571 86775619 
No. 18 Haishu Road Future Sci-TechSE DECISION MADE: 11-MAY-17
Hangzhou  CN ZJ571                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniTex Non-Sterile, Powder-Free, Latex Examination Glove
UG GLOBAL RESOURCES SDN BHD       510(k) NO: K161961(Traditional)
ATTN: Wong See Keong              PHONE NO : 60 06 6772751 
Lot 62 & 63, Lorong Senawang 3/2 KSE DECISION MADE: 11-MAY-17
Seremban  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Airworks Nebulizer pe1200m
Convexity Scientific LLC          510(k) NO: K162041(Traditional)
ATTN: Paul  Reiferson             PHONE NO : 203 5576254 
36 Church Lane                    SE DECISION MADE: 02-MAY-17
Westport CT  06880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MALUC™ Total Hip Arthroplasty System
SurgTech, Inc.,                   510(k) NO: K162125(Traditional)
ATTN: Xuegong  Yu                 PHONE NO : 
24600 Center Ridge Road, Suite 195SE DECISION MADE: 10-MAY-17
Westlake OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExSpiron 1Xi
Respiratory Motion Inc.           510(k) NO: K162131(Traditional)
ATTN: Edwin  Rule                 PHONE NO : 781 3731636 
411 Waverly Oaks Road, Building 1,SE DECISION MADE: 09-MAY-17
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VerteFIT Corpectomy Cage System
LDR SPINE USA, INC.               510(k) NO: K162133(Traditional)
ATTN: JAMIE  WILSON               PHONE NO : 512 3443355 
13785 RESEARCH BLVD SUITE 200     SE DECISION MADE: 16-MAY-17
AUSTIN TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Restore Moisturizing Vaginal Lubricant
Good Clean Love                   510(k) NO: K162207(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 West 5th Avenue               SE DECISION MADE: 04-MAY-17
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K162212(Traditional)
ATTN: LEE  GRANT                  PHONE NO : 901 3440807 
1800 PYRAMID PLACE                SE DECISION MADE: 19-MAY-17
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asahi ViE-U Series Dialyzer
ASAHI KASEI MEDICAL CO., LTD.     510(k) NO: K162248(Traditional)
ATTN: Masaharu  Aritomi           PHONE NO : 81 3 32963727 
1-105 KANDA JINBOCHO              SE DECISION MADE: 03-MAY-17
Chiyoda-ku  JP 101-8101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cedic Enteral ENFit Transition Connectors
CEDIC S.R.L.                      510(k) NO: K162254(Traditional)
ATTN: TIZIANA  MELIS              PHONE NO : 39 02 55300174 110
VIA LIBERAZIONE, 63/9             SE DECISION MADE: 04-MAY-17
PESCHIERA BORROMEO  IT 20068      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite Rheumatoid Factor Kit
THE BINDING SITE GROUP LTD.       510(k) NO: K162263(Traditional)
ATTN: JON  LAUDER                 PHONE NO : 44 0121 4569500 
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 03-MAY-17
BIRMINGHAM  GB B15 1QT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Cranial Fusion System
LIFE SPINE INC.                   510(k) NO: K162266(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 8846117 
13951 S QUALITY DRIVE             SE DECISION MADE: 01-MAY-17
HUNTLEY IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Sleeved Monolithic Revision Stems
SMITH & NEPHEW INC.               510(k) NO: K162303(Abbreviated)
ATTN: KIM  PHAN                   PHONE NO : 901 8003175 
7135 Goodlett Farms Parkway       SE DECISION MADE: 01-MAY-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Winner Transfer Wheelchair
Winner SG Pte Ltd                 510(k) NO: K162328(Traditional)
ATTN: Michael  Pang               PHONE NO : 65 9363 5453 
14 Little Road #07-01 Tropical IndSE DECISION MADE: 11-MAY-17
Singapore  SG 536987              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex Robotic System and Flex Colorectal Drive
Medrobotics Corporation           510(k) NO: K162330(Traditional)
ATTN: John D. Bonasera            PHONE NO : 508 6926460 
475 Paramount Drive               SE DECISION MADE: 04-MAY-17
Raynham MD  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wondfo One Step Fecal Occult Blood (FOB) Test
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K162333(Traditional)
ATTN: Bin  Chen                   PHONE NO : 86 20 32296069 
WONDFO SCIENTECH PARK, SOUTH CHINASE DECISION MADE: 14-MAY-17
GUANGZHOU  CN 510641              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABCcolla Collagen Matrix
ACRO BIOMEDICAL CO., LTD          510(k) NO: K162348(Traditional)
ATTN: DAR-JEN  HSIEH              PHONE NO : 886 7 6955569 
3F., NO.57, LUKE 2ND RD, LUJHU DISSE DECISION MADE: 10-MAY-17
Kaohsiung City  TW 82151          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FREND PSA PLUS (reagent cartridge)
NANOENTEK USA INC                 510(k) NO: K162378(Traditional)
ATTN: SUNMI  HAN                  PHONE NO : 925 2250108 
5627 STONERIDGE DRIVE SUITE 304   SE DECISION MADE: 17-MAY-17
PLEASANTON CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Locking Plate System
BEIJING KEYI MEDICAL DEVICE TECHNO510(k) NO: K162380(Traditional)
ATTN: CINDY  NIE                  PHONE NO : 86 10 67853877 
BUILDING 1, NO. 11, 3RD JINGHAI STSE DECISION MADE: 02-MAY-17
BEIJING  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avazzia
AVAZZIA, INC.                     510(k) NO: K162392(Traditional)
ATTN: TAMMY  LAHUTSKY             PHONE NO : 214 5752820 
13140 COIT ROAD SUITE 515         SE DECISION MADE: 12-MAY-17
DALLAS TX  75240                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gems Vitrification Set, Gems Warming Set
GENEA BIOMEDX PTY LTD             510(k) NO: K162409(Traditional)
ATTN: Kea  Dent                   PHONE NO : 61 284 847677 
LEVEL 2, 321 KENT STREET          SE DECISION MADE: 24-MAY-17
SYDNEY  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GCE Zen-O Portable Oxygen Concentrator
OXUS, INC                         510(k) NO: K162433(Traditional)
ATTN: RYAN  LENARCIC              PHONE NO : 248 7090490 
2676 PALDAN                       SE DECISION MADE: 24-MAY-17
AUBURN HILLS MI  48326            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
Cook Incorporated                 510(k) NO: K162448(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 26-MAY-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
ANGIODYNAMICS, INC                510(k) NO: K162449(Traditional)
ATTN: KASEY E NEWCOMB             PHONE NO : 508 6587913 
26 FOREST STREET                  SE DECISION MADE: 05-MAY-17
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Matrix Data Management System
GLOBAL INSTRUMENTATION, LLC       510(k) NO: K162463(Traditional)
ATTN: JASON  DEMASO               PHONE NO : 315 6820272 116
8104 CAZENOVIA ROAD               SE DECISION MADE: 24-MAY-17
MANLIUS NY  13104                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foundation 3D Interbody
CoreLink, LLC                     510(k) NO: K162496(Traditional)
ATTN: Stephan  Jones              PHONE NO : 888 3497808 
7911 Forsyth Blvd, Suite # 200    SE DECISION MADE: 04-MAY-17
St. Louis MO  63105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The IQool System
BRAIN COOL AB                     510(k) NO: K162523(Traditional)
ATTN: MARTIN  WALEIJ              PHONE NO : 46 733 937076 
SCHEELEVAGEN 2 MEDICON VILLAGE    SE DECISION MADE: 03-MAY-17
MEDICON VILLAGE  SE SE-223 81     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Creatine Kinase-MB
ROCHE DIAGNOSTICS                 510(k) NO: K162526(Traditional)
ATTN: NOEL B. MENCIAS             PHONE NO : 317 5213172 
9115 HAGUE ROAD                   SE DECISION MADE: 26-MAY-17
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoMed PINNACLE Driver
OSTEOMED                          510(k) NO: K162542(Traditional)
ATTN: KATHRYN A. JAYNE            PHONE NO : 972 6774766 
3885 ARAPAHO ROAD                 SE DECISION MADE: 19-MAY-17
ADDISON TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIK Sterile Acupuncture Needles for Single Use
CHANGCHUN AIK MEDICAL DEVICES CO.,510(k) NO: K162566(Traditional)
ATTN: XINGWANG  LI                PHONE NO : 86 1336 4688867 
NO. 25, KAREN INDUSTRIAL PARK, JIUSE DECISION MADE: 11-MAY-17
CHANGCHUN  CN 130507              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmCAD-US
AmCad BioMed Corporation          510(k) NO: K162574(Traditional)
ATTN: Jack  Yang                  PHONE NO : 866 2 27136227 
FL.3, NO. 167, Fu Hsing N. RD.    SE DECISION MADE: 30-MAY-17
Taipei  TW 105                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Craniomaxillofacial Distraction System (CMFD)
SYNTHES USA PRODUCTS, LLC         510(k) NO: K162594(Traditional)
ATTN: NICHOLAS  FOUNTOULAKIS      PHONE NO : 610 7196553 
1301 GOSHEN PARKWAY               SE DECISION MADE: 08-MAY-17
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAPI Seal
BISCO, INC.                       510(k) NO: K162598(Traditional)
ATTN: Ryan  Hobson                PHONE NO : 847 5346143 
1100 WEST IRVING PARK RD.         SE DECISION MADE: 23-MAY-17
SCHAUMBURG IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infusion Set for Single Use
SHINVA ANDE HEALTHCARE APPARATUS C510(k) NO: K162601(Traditional)
ATTN: Xiaolei  Tian               PHONE NO : 86 533 3917821 
NO.77 DEVELOPMENT ZONE NORTH RD   SE DECISION MADE: 31-MAY-17
Zibo  CN 255086                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo O3 Regional Oximeter System
MASIMO CORPORATION                510(k) NO: K162603(Traditional)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 2977683 
52 DISCOVERY                      SE DECISION MADE: 26-MAY-17
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Remel Spectra ESBL
REMEL, INC.                       510(k) NO: K162620(Traditional)
ATTN: CYNTHIA  KNAPP              PHONE NO : 800 8718909 332
12076 SANTA FE DRIVE              SE DECISION MADE: 01-MAY-17
LENEXA KS  66215                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive NuvaLine Mobile App
NUVASIVE, INCORPORATED            510(k) NO: K162647(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3204588 
7475 LUSK BLVD.                   SE DECISION MADE: 01-MAY-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kitazato IUI Catheter
Kitazato Corporation              510(k) NO: K162667(Traditional)
ATTN: Mari  Yazaki                PHONE NO : 81 3 58006055 
1-1-8 Shibadaimon, Minato-ku      SE DECISION MADE: 11-MAY-17
Tokyo  JP                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SL 220
Carl Zeiss Meditec AG             510(k) NO: K162684(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 3641 220301 
                                  SE DECISION MADE: 31-MAY-17
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bibag
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K162716(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 WINTER STREET                 SE DECISION MADE: 18-MAY-17
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CreoDent Solidex Customized Abutment
CreoDent Prosthetics, Ltd.        510(k) NO: K162734(Traditional)
ATTN: Calvin  Shim                PHONE NO : 212 3023860 
29 West 30th Street 11th Floor    SE DECISION MADE: 08-MAY-17
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
Surgical Instrument Services and S510(k) NO: K162751(Traditional)
ATTN: Brandi J Panteleon          PHONE NO : 541 9233310 
2747 SW 6th St.                   SE DECISION MADE: 01-MAY-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHAKOS Disposable Retinal Cryo Probe
PHAKOS                            510(k) NO: K162756(Traditional)
ATTN: OLIVER  AUMAITRE            PHONE NO : 33 4 9887400 
62 RUE KLEBER                     SE DECISION MADE: 03-MAY-17
MONTREUIL  FR 93100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPTIVATE™ Compression Screws
GLOBUS MEDICAL, INC.              510(k) NO: K162825(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 01-MAY-17
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C.T.M. Mobility Scooter
CHIEN TI ENTERPRISE CO., LTD.     510(k) NO: K162952(Traditional)
ATTN: VIVIAN  LO                  PHONE NO : 886 229 032987 
NO. 13, LANE 227, FU YING RD      SE DECISION MADE: 03-MAY-17
NEW TAIPEI CITY, HSIN CHUANG DISTR510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kangaroo Feeding Tube with IRIS Technology
Covidien (dba Medtronic)          510(k) NO: K163002(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 508 4524673 
15 Hampshire St                   SE DECISION MADE: 16-MAY-17
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T3 Software
ETIOMETRY, INC.                   510(k) NO: K163065(Traditional)
ATTN: DIMITAR  BARONOV            PHONE NO : 857 3669333 
119 BRAINTREE STREET SUITE 210    SE DECISION MADE: 26-MAY-17
BOSTON MA  02134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kent Camera
KENT IMAGING INC.                 510(k) NO: K163070(Traditional)
ATTN: Darrell  Barnhart           PHONE NO : 403 4557610 
1440, 720- 13TH AVENUE SW         SE DECISION MADE: 05-MAY-17
CALGARY  CA T2R 1M5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: vascuCAP
Elucid Bioimaging, Inc.           510(k) NO: K163071(Traditional)
ATTN: Andrew J. Buckler           PHONE NO : 978 4680508 
225 Main Street Suite 15          SE DECISION MADE: 24-MAY-17
Wenham MA  01984                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
Sol-Millennium Medical, Inc.      510(k) NO: K163073(Traditional)
ATTN: Jim  Barley                 PHONE NO : 404 9732200 
1735 North Brown Road, Suite 120  SE DECISION MADE: 19-MAY-17
Lawrenceville GA  30043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plasma Edge System
Chirurgie Innovation              510(k) NO: K163090(Third Party - Traditional)
ATTN: Guillaume  Noury            PHONE NO : 33 616 166330 
27 PLACE VICTOR SCHOELCHER        SE DECISION MADE: 23-MAY-17
MASSY  FR F-91300                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TinniLogic Mobile Tinnitus Management Device
JIANGSU BETTERLIFE MEDICAL CO., LT510(k) NO: K163094(Traditional)
ATTN: HONGWEI  XU                 PHONE NO : 86 512 52269378 
NO.11 SI HAI ROAD, CHANGSHU ECONOMSE DECISION MADE: 17-MAY-17
CHANGSHU  CN 215513               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alpha Pure
KOROAD AMERICA                    510(k) NO: K163117(Traditional)
ATTN: YEON JAE LEE                PHONE NO : 714 2136910 
895 DOVE ST, SUITE 300            SE DECISION MADE: 09-MAY-17
NEWPORT BEACH CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaviSuite SSI Edition
MEDCOM GMBH                       510(k) NO: K163119(Traditional)
ATTN: JOHANNES  MESSOW            PHONE NO : 49 615 195147258 
RUNDETURMSTR. 50                  SE DECISION MADE: 01-MAY-17
DARMSTADT  DE 64283               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A-dec NLZ Electric Motor System
NAKANISHI, INC.                   510(k) NO: K163131(Traditional)
ATTN: KIMIHIKO  SATOH             PHONE NO : 81 289 644325 
700 SHIMOHINATA                   SE DECISION MADE: 11-MAY-17
KANUMA-SHI  JP 322-8666           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
GEMSS MEDICAL SYSTEMS CO., LTD    510(k) NO: K163140(Traditional)
ATTN: Sang Woo Lee                PHONE NO : 82 31 7647321 
2nd Floor, 29, Dunchon-daero 541 bSE DECISION MADE: 26-MAY-17
Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
SMITHS MEDICAL ASD, INC.          510(k) NO: K163172(Traditional)
ATTN: Bruce  Backlund             PHONE NO : 763 3833265 
6000 NATHAN LANE N                SE DECISION MADE: 24-MAY-17
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRANSLACE™ Spinal Tethering System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K163181(Traditional)
ATTN: Becky  Ronner               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 16-MAY-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACTION II Laser System
LUTRONIC CORPORATION              510(k) NO: K163196(Traditional)
ATTN: Jhung Won Vojir             PHONE NO : 82 31 9083440 
219, SOWON-RO, HAENGSIN-DONG      SE DECISION MADE: 24-MAY-17
DEOGYANG-GU, GOYANG-SI  KR 410-722510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Holmium Laser Fiber
COOK INCORPORATED                 510(k) NO: K163197(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 DANIELS WAY, P.O. BOX 489     SE DECISION MADE: 24-MAY-17
BLOOMINGTON IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A08 Power wheelchair
Kunshan Aoshida Electric Technolog510(k) NO: K163204(Traditional)
ATTN: Shen  Wenhua                PHONE NO : 86 512 57816288 
No. 65, Matang Road               SE DECISION MADE: 05-MAY-17
Kunshan  CN 215300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIC Extremely Small Staple
Epic Extremely, LLC               510(k) NO: K163226(Traditional)
ATTN: Dan  Schwartzbauer          PHONE NO : 412 9560302 
120 Marguerite Dr, Ste 301        SE DECISION MADE: 16-MAY-17
Cranberry Twp PA  16066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse Kiss Zirconia
AMS                               510(k) NO: K163238(Traditional)
ATTN: HYUNA  KIM                  PHONE NO : 82 708 7182828 
#530 NA-DONG MACHZONE, 117, HWANGGSE DECISION MADE: 04-MAY-17
GYEONGGI-DO  KR 10048             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA MEDICAL, INC.                 510(k) NO: K163244(Traditional)
ATTN: Sherrie  Coval-Goldsmith    PHONE NO : 781 5384720 
91 HARTWELL AVENUE                SE DECISION MADE: 24-MAY-17
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longitudinal Brain Imaging (LoBI) application
Philips Medical Systems Nederland 510(k) NO: K163250(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 1 800 7229377 
Veenpluis 4-6 5684 PC Best        SE DECISION MADE: 11-MAY-17
Best Noord-Brabant  NL 5684 PC    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitreOx Anti-fog Solution
SiO2 Nanotech, LLC                510(k) NO: K163257(Traditional)
ATTN: CLARIZZA  WATSON            PHONE NO : 602 5653447 
275 N. GATEWAY DRIVE SUITE 126    SE DECISION MADE: 24-MAY-17
PHOENIX AZ  85034                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
ATRICURE INC.                     510(k) NO: K163261(Traditional)
ATTN: Jonathan  McElwee           PHONE NO : 513 6444249 
7555 Innovation Way               SE DECISION MADE: 19-MAY-17
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ANDON HEALTH CO.,LTD              510(k) NO: K163276(Abbreviated)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161 9060
NO 3,  JIN PING ST, YA AN RD NANKASE DECISION MADE: 11-MAY-17
TIANJIN  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Colink™ Plating System
IN2BONESUSA, LLC                  510(k) NO: K163293(Traditional)
ATTN: JOE  CLIFT                  PHONE NO : 901 2607931 
6060 POPLAR AVE SUITE 380         SE DECISION MADE: 05-MAY-17
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Internal Distraction - Sterile
KLS Martin LP                     510(k) NO: K163315(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 05-MAY-17
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precifit Medical Kirschner Wires
PRECIFIT MEDICAL LTD              510(k) NO: K163327(Traditional)
ATTN: ZHEN YU(ERIC) WU            PHONE NO : 
951 AVIATION PKWY STE 100         SE DECISION MADE: 08-MAY-17
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS V3 Conical Connection Dental Implant System­
MIS Implants Technologies Ltd.    510(k) NO: K163349(Traditional)
ATTN: Arbel  Shezaf               PHONE NO : 972 4 9016800 
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 26-MAY-17
Bar Lev Industrial Park  IL 201560510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse* Spray Infusion Catheter System, Uni*Fuse Infusion Catheter
ANGIODYNAMICS, INC.               510(k) NO: K163356(Traditional)
ATTN: ROBIN  FULLER               PHONE NO : 508 6587986 
26 FOREST STREET                  SE DECISION MADE: 30-MAY-17
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
PHADIA AB                         510(k) NO: K163370(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 05-MAY-17
Uppsala  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oxitone 1000
Oxitone Medical Ltd.              510(k) NO: K163382(Traditional)
ATTN: Leon  Eisen                 PHONE NO : 972 9 8346731 
17 Atir Yeda Street               SE DECISION MADE: 09-MAY-17
Kfar Saba  IL 4464312             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hybrid3D
Hermes Medical Solutions AB       510(k) NO: K163394(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 8 190325 
Skeppsbron 44                     SE DECISION MADE: 22-MAY-17
Stockholm  SE 11130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prontosan Wound Gel
B. Braun Medical, Inc.            510(k) NO: K163430(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 610 5962796 
901 Marcon Boulevard              SE DECISION MADE: 23-MAY-17
Allentown PA  18109-9341          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
Cook Ireland Ltd.                 510(k) NO: K163468(Traditional)
ATTN: Jacinta  Kilmartin          PHONE NO : 011 353 61239483 
O'Halloran Road, National TechnoloSE DECISION MADE: 04-MAY-17
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lubricity
You First Services, Incorporated  510(k) NO: K163476(Traditional)
ATTN: Jeffrey  Eberhard           PHONE NO : 716 2047215 
1576 Sweet Home Road              SE DECISION MADE: 10-MAY-17
Amherst NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical                    510(k) NO: K163481(Traditional)
ATTN: Troy  Taylor                PHONE NO : 760 8148047 
5670 El Camino Real Suite B       SE DECISION MADE: 03-MAY-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthodontic Acrylic 2
Lang Dental Manufacturing Co., Inc510(k) NO: K163482(Traditional)
ATTN: Dave  Lang                  PHONE NO : 847 2156622 
175 Messner Drive PO Box 969      SE DECISION MADE: 31-MAY-17
Wheeling IL  60090                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSR'obot Biopsy Kit
Biobot Surgical Pte Ltd           510(k) NO: K163502(Traditional)
ATTN: Lai Chee LIEW               PHONE NO : 65 6351 1868 
79, Ayer Rajah Crescent, #04-05/06SE DECISION MADE: 16-MAY-17
Singapore  SG 139955              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIETTA PRECISION
HITACHI, LTD                      510(k) NO: K163505(Traditional)
ATTN: ANGELA VAN ARSDALE          PHONE NO : 203 2695088 346
10 FAIRFIELD BOULEVARD            SE DECISION MADE: 30-MAY-17
WALLINGFORD CT  06492-5903        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PrisMax Control Unit
BAXTER HEALTHCARE CORP            510(k) NO: K163530(Traditional)
ATTN: Chris  Scavotto             PHONE NO : 763 4634621 
7601 Northland Drive Suite 170    SE DECISION MADE: 03-MAY-17
Brooklyn Park MN  55428           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue
HEBEI TITANS MEDICAL SUPPLY TECHNO510(k) NO: K163553(Traditional)
ATTN: Shaozhang  Nan              PHONE NO : 86 319 7295820 
EAST OF JINGQIANG COMMUNITY, DAQINSE DECISION MADE: 22-MAY-17
NANGONG  CN 051800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SS SA Fixture
OSSTEM IMPLANT Co., Ltd.          510(k) NO: K163557(Traditional)
ATTN: Mr.  HeeKwon                PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 15-MAY-17
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLIT LAMP SL-2000
NIDEK CO., LTD.                   510(k) NO: K163564(Traditional)
ATTN: Yoneji  Mizuno              PHONE NO : 81 533 678901 
34-14 Maehama, Hiroishicho        SE DECISION MADE: 19-MAY-17
Gamagori  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE SYNECOR Preperitoneal Biomaterial
W. L. Gore & Associates, Inc.     510(k) NO: K163576(Traditional)
ATTN: Michael J. Titus            PHONE NO : 410 5068316 
1505 N. Fourth Street             SE DECISION MADE: 11-MAY-17
Flagstaff AZ  86004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Blood Pressure Monitor-Automatic Upper Arm Style
Shenzhen Combei Technology CO., LT510(k) NO: K163606(Traditional)
ATTN: Huaguang  Meng              PHONE NO : 86 0755 2958896 
Floor 5, Block B, Building G, JinxSE DECISION MADE: 09-MAY-17
Guanlan, Shenzhen  CN 518110      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOTOME M+, PIEZOTOME M+ Handpiece
SATALEC-ACTEON GROUP              510(k) NO: K163610(Traditional)
ATTN: PHILIPPE  GIRARD            PHONE NO : 11 335 56340607 
17 AVENUE GUSTAVE EIFFEL          SE DECISION MADE: 19-MAY-17
MERIGNAC  FR 33708                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
CareFusion 2200 Inc               510(k) NO: K163615(Traditional)
ATTN: Jane  Weber                 PHONE NO : 847 3628094 
75 North Fairway Drive            SE DECISION MADE: 04-MAY-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INDIGO Aspiration System
PENUMBRA, INC.                    510(k) NO: K163618(Traditional)
ATTN: RICHARD  KIMURA             PHONE NO : 510 9952034 
ONE PENUMBRA PLACE                SE DECISION MADE: 24-MAY-17
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitoss Bioactive (BA) Injectable
Orthovita, Inc.                   510(k) NO: K163621(Traditional)
ATTN: John  Rossman               PHONE NO : 610 6401775 
45 Great Valley Parkway           SE DECISION MADE: 02-MAY-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lung Vision
BODY VISION MEDICAL LTD.          510(k) NO: K163622(Traditional)
ATTN: DORIAN  AVERBUCH            PHONE NO : 646 8637848 
34 SOKOLOV ST.                    SE DECISION MADE: 11-MAY-17
RAMAT HASHARON  IL                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Luminex Corporation               510(k) NO: K163626(Traditional)
ATTN: Kate  Linak                 PHONE NO : 608 2038909 
12212 Technology Blvd             SE DECISION MADE: 02-MAY-17
Austin TX  78727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental 5 Multi Diode laser
BIO-MED USA INC                   510(k) NO: K163638(Traditional)
ATTN: YOUNG  CHI                  PHONE NO : 1 973 2785222 
111 ELLISON STREET                SE DECISION MADE: 15-MAY-17
PATERSON NJ  07505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QZA and RS Dental Implant Systems
TRINON Titanium GmbH              510(k) NO: K163640(Abbreviated)
ATTN: Katja  Lvova                PHONE NO : 49 72 1932700 
Augartenstr. 1                    SE DECISION MADE: 03-MAY-17
Karlsruhe  DE 76137               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden QP-160AK EEG Trend Program
Nihon Kohden Corporation          510(k) NO: K163644(Traditional)
ATTN: Tom  Bento                  PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-Ku   SE DECISION MADE: 19-MAY-17
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K163658(Traditional)
ATTN: Darius  Daruwala            PHONE NO : 914 5242812 
511 Benedict Avenue               SE DECISION MADE: 23-MAY-17
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATRx plus
Zephyr Sleep Technologies         510(k) NO: K163665(Traditional)
ATTN: Sabina  Bruehlmann          PHONE NO : 1 877 3418814 
610A 70 Ave SE                    SE DECISION MADE: 05-MAY-17
Calgary  CA T2H-2J6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Humeris Shoulder
Fx Solutions                      510(k) NO: K163669(Traditional)
ATTN: Jean-Jacques  Martin        PHONE NO : 33 4 74553555 
1663 Rue de Majornas              SE DECISION MADE: 17-MAY-17
Viriat  FR 01440                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart One Lumbar Interbody Fusion Device
SPINEOLOGY INC.                   510(k) NO: K163670(Traditional)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3RD STREET N., SUITE 600     SE DECISION MADE: 08-MAY-17
ST. PAUL MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
NANOVA BIOMATERIALS, INC.         510(k) NO: K163672(Traditional)
ATTN: ANDREW  RITTS               PHONE NO : 573 8756682 
3806 MOJAVE CT                    SE DECISION MADE: 05-MAY-17
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortilink™-C with TETRAfuse™ 3D Technology
RTI Surgical, Inc.                510(k) NO: K163673(Traditional)
ATTN: Diana  Taylor               PHONE NO : 386 4188888 4384
11621 Research Circle             SE DECISION MADE: 23-MAY-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
A&D COMPANY, LTD                  510(k) NO: K163683(Special)
ATTN: JERRY  WANG                 PHONE NO : 408 5185113 
1756 AUTOMATION PARKWAY           SE DECISION MADE: 03-MAY-17
SAN JOSE CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Direxion and Direxion HI-FLO Torqueable Microcatheters
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K163701(Special)
ATTN: LIZ  JOHNSTON               PHONE NO : 763 4941676 
THREE SCIMED PLACE                SE DECISION MADE: 16-MAY-17
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K163702(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 30-MAY-17
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive CoRoent Ti-C System
NuVasive, Incorporated            510(k) NO: K163707(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 01-MAY-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.             510(k) NO: K170007(Traditional)
ATTN: James A. Bonafini           PHONE NO : 585 4589409 
1667 Lake Avenue, Suite 354       SE DECISION MADE: 31-MAY-17
Rochester NY  14615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StealthStation S8 Spine Software v1.0.0
MEDTRONIC NAVIGATION              510(k) NO: K170011(Traditional)
ATTN: JOHN  CONNOR                PHONE NO : 720 8902311 
826 COAL CREEK CIRCLE             SE DECISION MADE: 01-MAY-17
LOUISVILLE CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StealthStationTM S8 ENT Software
Medtronic Navigation, Inc.        510(k) NO: K170018(Traditional)
ATTN: K. Elizabeth Waite          PHONE NO : 720 8903200 
826 Coal Creek Circle             SE DECISION MADE: 19-MAY-17
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMV Scientific Cannulated Screws
SMV Scientific                    510(k) NO: K170021(Traditional)
ATTN: Nephi  Zufelt               PHONE NO : 512 7508622 
111 Sandra Muraida Way Unit 18A   SE DECISION MADE: 22-MAY-17
Austin TX  78703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPiN Thoracic Navigation System
Veran Medical Technologies, Inc.  510(k) NO: K170023(Traditional)
ATTN: Scott  Wrightstone          PHONE NO : 314 6598500 
1908 Innerbelt Business Center Dr SE DECISION MADE: 15-MAY-17
St. Louis MO  63114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AssureTech Panel Dip Test, AssureTech Quick Cup Test
ASSURE TECH (HANGZHOU) CO., LTD.  510(k) NO: K170049(Traditional)
ATTN: SHISHENG  LING              PHONE NO : 86 571 88868960 
NO.10, XIYUANSAN RD. WESTLAKE ECONSE DECISION MADE: 02-MAY-17
HANGZHOU  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Softcure 96
WELLRAY MEDICAL LASER, INC.       510(k) NO: K170068(Traditional)
ATTN: Richard O DeRoberts         PHONE NO : 304 8744209 
216 Moores Run Rd.                SE DECISION MADE: 05-MAY-17
Wardensville WV  26851            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
MEDISONO, LLC                     510(k) NO: K170078(Abbreviated)
ATTN: JORGE  MILLAN               PHONE NO : 786 4165587 
3511 SILVERSIDE RD STE 105        SE DECISION MADE: 17-MAY-17
WILMINGTON DE  19810              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Test of Variables of Attention (T.O.V.A.) Version 9.0
THE TOVA COMPANY                  510(k) NO: K170082(Traditional)
ATTN: CHRIS  HOLDER               PHONE NO : 360 6612899 
2828 SW CORBETT AVE SUITE 128     SE DECISION MADE: 17-MAY-17
PORTLAND OR  97201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcceleDent Optima
OrthoAccel Technology Inc.        510(k) NO: K170093(Traditional)
ATTN: Jouana  Harris-Livings      PHONE NO : 832 7694632 
6575 West Loop South, Suite 200   SE DECISION MADE: 26-MAY-17
Bellaire TX  77401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgi Max Ultra
elliquence, LLC                   510(k) NO: K170107(Traditional)
ATTN: Paul D. Buhrke IV           PHONE NO : 516 2779010 
2455 Grand Avenue                 SE DECISION MADE: 03-MAY-17
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xultan 5.5 Pedicle Screw System
Met One Technologies              510(k) NO: K170108(Traditional)
ATTN: Dan  Gerbec                 PHONE NO : 915 3010834 
154 N. Festival Dr., Ste. F       SE DECISION MADE: 02-MAY-17
El Paso TX  79912                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
Pulsaderm LLC                     510(k) NO: K170111(Traditional)
ATTN: Gloria  Avendano            PHONE NO : 239 2087541 
12801 COMMONWEALTH DR. UNITS 2-6  SE DECISION MADE: 08-MAY-17
Fort Myers FL  33913              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagVita TMS Therapy - w/MagPro R20
TONICA ELEKTRONIK A/S             510(k) NO: K170114(Traditional)
ATTN: LISE  TERKELSEN             PHONE NO : 45 44 998444 
LUCERNEMARKEN 15                  SE DECISION MADE: 01-MAY-17
FARUM  DK DK-3520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Lumenis Ltd.                      510(k) NO: K170121(Special)
ATTN: Yehudit  Kraizer            PHONE NO : 972 54 9599172 
Yokneam Industrial Park, 6 HakidmaSE DECISION MADE: 22-MAY-17
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FFR V2.5
Philips Volcano                   510(k) NO: K170133(Traditional)
ATTN: Elaine  Alan                PHONE NO : 858 7641281 
3721 Valley Ctr. Dr.              SE DECISION MADE: 26-MAY-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TREFOIL System
Nobel Biocare AB                  510(k) NO: K170135(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 11-MAY-17
Goteberg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
Stimwave Technologies Incorporated510(k) NO: K170141(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 800 9655134 
901 East Las Olas Boulevard, SuiteSE DECISION MADE: 02-MAY-17
Fort Lauderdale FL  33301         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
HARTALEGA SDN BHD                 510(k) NO: K170152(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 62771733 
DATARAN SD PJU 9                  SE DECISION MADE: 05-MAY-17
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: UNiD Spine Analyzer
MEDICREA INTERNATIONAL            510(k) NO: K170172(Traditional)
ATTN: David  Ryan                 PHONE NO : 00 33 472018787 
5389 Route de Strasbourg-Vancia   SE DECISION MADE: 24-MAY-17
Rillieux La Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultravision Visual Field Clearing System
Alesi Surgical Ltd.               510(k) NO: K170178(Traditional)
ATTN: DAVID  BRODERICK            PHONE NO : 44 02920 1022 
Cardiff MediCentre, Heath Park    SE DECISION MADE: 26-MAY-17
Cardiff  GB CF14 4UJ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Will3D
HDX WILL CORP.                    510(k) NO: K170180(Traditional)
ATTN: Seung-Il  Chun              PHONE NO : 82 43 7107318 
#105, 201, 202, 203, 204, 38, OsonSE DECISION MADE: 08-MAY-17
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuantX
Quantitative Insights, Inc.       510(k) NO: K170195(Traditional)
ATTN: Robert  Tomek               PHONE NO : 773 9604670 
1452 E 53rd St.                   SE DECISION MADE: 17-MAY-17
Chicago IL  60615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
A&D Company, Ltd.                 510(k) NO: K170196(Special)
ATTN: Jerry  Wang                 PHONE NO : 408 5185113 
1756 Automation Parkway           SE DECISION MADE: 17-MAY-17
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Network ID
GE Healthcare                     510(k) NO: K170199(Special)
ATTN: Robert  Casarsa             PHONE NO : 414 3623063 
8200 West Tower Ave.              SE DECISION MADE: 12-MAY-17
Milwaukee WI  53223               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
Shenzhen Kentro Medical Electronic510(k) NO: K170205(Traditional)
ATTN: Zewu  Zhang                 PHONE NO : 86 755 33825998 
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 11-MAY-17
Shenzhen City  CN 518115          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexitouch System
Tactile Systems Technology, Inc (d510(k) NO: K170216(Traditional)
ATTN: Thomas A. Dold              PHONE NO : 612 3555100 
1331 Tyler Street NE, Suite 200   SE DECISION MADE: 26-MAY-17
Minneapolis MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Belimed Steam Sterilizer MST-H TOP 5000
Belimed AG                        510(k) NO: K170228(Abbreviated)
ATTN: Christoph  Hermens          PHONE NO : 41 41 4497888 
Grienbachstrasse 11               SE DECISION MADE: 12-MAY-17
Zug  CH 6300                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiGen™ 2 RF Generator System
STRYKER CORPORATION               510(k) NO: K170242(Traditional)
ATTN: BECKY  DITTY                PHONE NO : 269 3893434 
4100 E. MILHAM AVE                SE DECISION MADE: 25-MAY-17
KALAMAZOO MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DSM Biomedical Dental Bone Graft
Kensey Nash Corporation dba DSM Bi510(k) NO: K170245(Traditional)
ATTN: Susan  Pileggi              PHONE NO : 484 7132100 
735 Pennsylvania Drive            SE DECISION MADE: 16-MAY-17
Exton PA  19341                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS
TRUABUTMENT                       510(k) NO: K170259(Traditional)
ATTN: BRANDON  KIM                PHONE NO : 714 9561488 
300 SOUTH HARBOR BLVD #520        SE DECISION MADE: 25-MAY-17
ANAHEIM CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hee HR Mini
Oriental Inspiration Limited      510(k) NO: K170269(Traditional)
ATTN: Andy  Wu                    PHONE NO : 852 2687 3496 
Unit 607, The Lakeside 2, West WinSE DECISION MADE: 03-MAY-17
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
C.R. BARD INC.                    510(k) NO: K170278(Traditional)
ATTN: KATHERINE  EARLE            PHONE NO : 401 8258450 
100 CROSSINGS BOULEVARD           SE DECISION MADE: 31-MAY-17
WARWICK RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew VISIONAIRE Adaptive Guides
Smith & Nephew, Inc               510(k) NO: K170282(Traditional)
ATTN: Brad  Sheals                PHONE NO : 901 3996897 
7135 Goodlett Farms Parkway       SE DECISION MADE: 22-MAY-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implants OKTAGON Bone Level Tapered Design
Hager& Meisinger GmbH             510(k) NO: K170287(Traditional)
ATTN: Melanie  May                PHONE NO : 0049 2131 2012292 
Hansemannstrasse 10               SE DECISION MADE: 24-MAY-17
Neuss  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
Shen Wei USA Inc.                 510(k) NO: K170290(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave. Suite 102      SE DECISION MADE: 24-MAY-17
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: IontoDC
SOTERIX MEDICAL,INC.              510(k) NO: K170291(Traditional)
ATTN: ABHISHEK  DATTA             PHONE NO : 888 9908327 
237 W 35 ST, 1401                 SE DECISION MADE: 01-MAY-17
NEW YORK NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse,  VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval
CR BARD                           510(k) NO: K170294(Traditional)
ATTN: CHRISTINE  LLOYD            PHONE NO : 401 8258447 
100 CROSSING BLVD                 SE DECISION MADE: 01-MAY-17
WARWICK RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E5 Series Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP.           510(k) NO: K170303(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f, yizhe bSE DECISION MADE: 19-MAY-17
shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT BG Putty Bone Graft Substitute
Prosidyan, Inc                    510(k) NO: K170306(Traditional)
ATTN: Charanpreet S. Bagga        PHONE NO : 908 5173666 
30 Technology Drive               SE DECISION MADE: 24-MAY-17
Warren NJ  07059                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Extended Enteric Bacterial Panel, BD MAX System
BECTON, DICKINSON AND COMPANY     510(k) NO: K170308(Traditional)
ATTN: LAURA  STEWART              PHONE NO : 410 3164435 
7 LOVETON CIRCLE                  SE DECISION MADE: 02-MAY-17
SPARKS MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K170312(Traditional)
ATTN: DEEP  PAL                   PHONE NO : 817 7886400 
4620 NORTH BEACH ST               SE DECISION MADE: 15-MAY-17
FORT WORTH TX  76137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalys Precision Laser System
Abbott Medical Optics Inc.        510(k) NO: K170322(Traditional)
ATTN: Audrey  Munnerlyn           PHONE NO : 408 2734106 
510 Cottonwood Drive              SE DECISION MADE: 19-MAY-17
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
RevMedx, Inc.                     510(k) NO: K170334(Traditional)
ATTN: Amy K. Pointer              PHONE NO : 503 2182172 
25999 SW Canyon Creek Road, Suite SE DECISION MADE: 01-MAY-17
Wilsonville OR  97070             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A-View
Stroke2Prevent B.V.               510(k) NO: K170338(Traditional)
ATTN: Maarten  Nibbelke           PHONE NO : 31 038 3032630 
Dokter Stolteweg 70               SE DECISION MADE: 16-MAY-17
8025 AZ Zwolle  NL 8025           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ocata Anterior Cervical System
Kalitec Direct, LLC               510(k) NO: K170342(Traditional)
ATTN: Scott  Winn                 PHONE NO : 407 5452063 
618 E. South Street Suite 500     SE DECISION MADE: 09-MAY-17
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RA-308 Excimer Laser System, Excimer Laser Catheter
Ra Medical Systems, Inc.          510(k) NO: K170349(Traditional)
ATTN: Dean  Irwin                 PHONE NO : 877 6351800 
1930 Kellogg Ave.                 SE DECISION MADE: 24-MAY-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVIO
Blue Belt Technologies, Inc.      510(k) NO: K170360(Traditional)
ATTN: Richard G. Confer           PHONE NO : 763 4524950 
2905 Northwest Blvd. Ste. 40      SE DECISION MADE: 02-MAY-17
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceribell Pocket EEG Device
Ceribell, Inc.                    510(k) NO: K170363(Traditional)
ATTN: Josef  Parvizi              PHONE NO : 650 5217003 
2483 Old Middlefield Way, Suite 12SE DECISION MADE: 08-MAY-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collagen Meniscus Implant XL
Ivy Sports Medicine, LLC          510(k) NO: K170364(Traditional)
ATTN: John  Dichiara              PHONE NO : 650 5620800 
545 Penobscot Drive               SE DECISION MADE: 02-MAY-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRASHAPE POWER SYSTEM
Syneron Medical Ltd.              510(k) NO: K170370(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 73 2442200 
Tavor Building, Industrial Zone, PSE DECISION MADE: 15-MAY-17
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Compression Screws
Arthrex Inc.                      510(k) NO: K170382(Special)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 11-MAY-17
Naples FL  34108-5553             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
Zibo Chengxun Automatic Device Co.510(k) NO: K170393(Traditional)
ATTN: Ding  Wei                   PHONE NO : 86 533 2341615 
No. 37 Minan Road, High-tech IndusSE DECISION MADE: 09-MAY-17
Zibo  CN 255088                   510(k) STATEMENT
                                                    

DEVICE: Piccolo Composite® Plate System
CarboFix Orthopedics Ltd.         510(k) NO: K170401(Traditional)
ATTN: Yael  Rubin                 PHONE NO : 972 9 9511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 12-MAY-17
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
Bio-Rad Laboratories              510(k) NO: K170413(Traditional)
ATTN: Juang  Wang                 PHONE NO : 510 7414609 
5500 E. 2nd Street                SE DECISION MADE: 11-MAY-17
Benicia CA  94510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiCase Viewer
Materialise NV                    510(k) NO: K170419(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 163 96280 
Technologielaan 15                SE DECISION MADE: 11-MAY-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KISSloc Suture System
Arthrosurface, Inc                510(k) NO: K170440(Traditional)
ATTN: Dawn J. Wilson              PHONE NO : 508 5203003 
28 Forge Parkway                  SE DECISION MADE: 03-MAY-17
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LT-300 SD Digital Video Colposcope
Lutech Industries, Inc.           510(k) NO: K170446(Traditional)
ATTN: Leanna  Vachula             PHONE NO : 631 5846688 
105 Remington Blvd Suite C        SE DECISION MADE: 21-MAY-17
Ronkonkoma NY  11779              510(k) STATEMENT
                                                    

DEVICE: KARL STORZ ShuntScope
KARL STORZ Endoscopy-America, Inc.510(k) NO: K170462(Traditional)
ATTN: Susie S. Chen               PHONE NO : 424 2188201 
2151 E. Grand Avenue              SE DECISION MADE: 16-MAY-17
EI Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxStage System One Plus
NxStage Medical, Inc              510(k) NO: K170469(Traditional)
ATTN: Randall  Covill             PHONE NO : 978 2984163 
350 Merrimack Street              SE DECISION MADE: 09-MAY-17
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SICAGE™ System
Sicage LLc                        510(k) NO: K170475(Traditional)
ATTN: Kristi  Vondra              PHONE NO : 605 2716103 
6709 S. Minnesota Ave, Suite 206  SE DECISION MADE: 05-MAY-17
Souix Falls SD  57108             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Strep B Carrot Broth Kit
Hardy Diagnostics                 510(k) NO: K170481(Traditional)
ATTN: Rianna  Malherbe            PHONE NO : 805 3462766 
1430 West McCoy Lane              SE DECISION MADE: 16-MAY-17
Santa Maria CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATHTONG II PICC Catheter
L&Z US, Inc.                      510(k) NO: K170486(Special)
ATTN: Jenella  Coutts             PHONE NO : 718 6010889 1
6 Horizon Road                    SE DECISION MADE: 25-MAY-17
Fort Lee NJ  07024                510(k) STATEMENT
                                                    

DEVICE: Skylit Phototherapy System
Skylit Medical                    510(k) NO: K170489(Traditional)
ATTN: Martyn  Gross               PHONE NO : 858 3484959 
4225 Executive Square, Suite 420  SE DECISION MADE: 23-MAY-17
La Jolla CA  92037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solana C. difficile Assay
Quidel Corporation                510(k) NO: K170491(Traditional)
ATTN: Ronald H. Lollar            PHONE NO : 740 5893373 
2005 East State Street, Suite 100 SE DECISION MADE: 11-MAY-17
Athens OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
Stryker Corporation               510(k) NO: K170496(Traditional)
ATTN: Meriam  Gabera              PHONE NO : 201 7608043 
2 Pearl Court                     SE DECISION MADE: 16-MAY-17
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIROLaser Advance+
Dentsply Sirona                   510(k) NO: K170500(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 16-MAY-17
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
Bio-Rad Laboratories              510(k) NO: K170509(Traditional)
ATTN: Arlene  Carillo             PHONE NO : 510 7414613 
5500 East Second Street           SE DECISION MADE: 19-MAY-17
Benicia CA  94510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Central Monitoring System
Guangdong Biolight Meditech Co., L510(k) NO: K170514(Traditional)
ATTN: Jin  Liang                  PHONE NO : 86 756 3399967 
No.2 Innovation First Road, TechniSE DECISION MADE: 24-MAY-17
Zhuhai  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRINITY/3D PROSTATE SUITE
KOELIS                            510(k) NO: K170521(Traditional)
ATTN: Laetitia  GERVAIS           PHONE NO : 33 458 176810 
16, chemin du vieux chene         SE DECISION MADE: 30-MAY-17
MEYLAN  FR 38240                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIPER PRIME™ Screws with Fenestrations
Medos International, SARL         510(k) NO: K170543(Traditional)
ATTN: Karen  Sylvia               PHONE NO : 508 9773804 
Chemin-Blanc 38                   SE DECISION MADE: 04-MAY-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenePOC GBS LB
GenePOC Inc.                      510(k) NO: K170557(Traditional)
ATTN: Guy  Sevigny                PHONE NO : 1 418 6503535 
360 rue Franquet                  SE DECISION MADE: 25-MAY-17
Quebec  CA G1P 4N3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: revogene
GenePOC Inc.                      510(k) NO: K170558(Traditional)
ATTN: Guy  Sevigny                PHONE NO : 1 418 6503535 
360 rue Franquet                  SE DECISION MADE: 25-MAY-17
Quebec  CA G1P 4N3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Empowr CR Knee Tibial Insert
Encore Medical, L.P.              510(k) NO: K170573(Traditional)
ATTN: Desiree  Wells              PHONE NO : 512 8346302 
9800 Metric Blvd.                 SE DECISION MADE: 31-MAY-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
Ever Global (Vietnam) Enterprise C510(k) NO: K170575(Abbreviated)
ATTN: Jerry  Lin                  PHONE NO : 84 613 514022 
Long Thanh Industrial Zone Taman VSE DECISION MADE: 16-MAY-17
Dong Nai Province  VN 810000      510(k) STATEMENT
                                                    

DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
LENSAR, Inc.                      510(k) NO: K170576(Traditional)
ATTN: Keith  Peck                 PHONE NO : 888 5756412 
2800 Discovery Drive, Suite 100   SE DECISION MADE: 05-MAY-17
ORLANDO FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Knee Application
MAKO Surgical Corp.               510(k) NO: K170581(Special)
ATTN: Shikha  Khandelwal          PHONE NO : 201 8316921 
2555 Davie Rd                     SE DECISION MADE: 11-MAY-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Partial Knee Application
MAKO Surgical Corp.               510(k) NO: K170584(Special)
ATTN: Shikha  Khandelwal          PHONE NO : 201 8316921 
2555 Davie Rd                     SE DECISION MADE: 11-MAY-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Strep B Carrot Broth One-Step
Hardy Diagnostics                 510(k) NO: K170586(Traditional)
ATTN: Christopher  Massey         PHONE NO : 805 3462766 5620
1430 West McCoy Lane              SE DECISION MADE: 22-MAY-17
Santa Maria CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I.B.S. osteosynthesis screws
In2Bones SAS                      510(k) NO: K170594(Special)
ATTN: Morgane  Grenier            PHONE NO : 33 4 72292626 
28 Chemin du Petit Bois           SE DECISION MADE: 10-MAY-17
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
Syneron Candela Corporation       510(k) NO: K170597(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 508 3587400 330
530 Boston Post Road              SE DECISION MADE: 25-MAY-17
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tao Brush I.U.M.C. Endometrial Sampler
Cook Incorporated                 510(k) NO: K170603(Traditional)
ATTN: Ian  Herman                 PHONE NO : 812 3353575 104034
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 24-MAY-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Respiratory Panel 2 (RP2)
BioFire Diagnostics, LLC          510(k) NO: K170604(Traditional)
ATTN: Kristen J. Kanack           PHONE NO : 801 7366354 330
515 Colorow Drive                 SE DECISION MADE: 30-MAY-17
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SETx Pedicle Screw System
Xenco Medical, LLC                510(k) NO: K170611(Traditional)
ATTN: Gustavo  Prado              PHONE NO : 858 2021505 
9930 Mesa Rim Road                SE DECISION MADE: 25-MAY-17
San Diego CA  92121               510(k) STATEMENT
                                                    

DEVICE: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
Alma Lasers Inc.                  510(k) NO: K170626(Traditional)
ATTN: Rekha  Anand                PHONE NO : 224 3772000 2019
485 Half Day Road Suite # 100     SE DECISION MADE: 31-MAY-17
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE Anchor with PERMATAPE Suture
Medos International SARL          510(k) NO: K170639(Traditional)
ATTN: Julie  Vafides              PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 18-MAY-17
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Connector System
Orthofix Inc.                     510(k) NO: K170647(Traditional)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 11-MAY-17
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTHEM CR Total Knee System
Smith & Nephew, Inc.              510(k) NO: K170648(Traditional)
ATTN: Thomas  Fearnley            PHONE NO : 901 3991224 
7135 Goodlett Farms Parkway       SE DECISION MADE: 11-MAY-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Orthofix Srl                      510(k) NO: K170650(Special)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 10-MAY-17
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lympha Press Optimal Plus
Mego Afek AC Ltd.                 510(k) NO: K170658(Traditional)
ATTN: Reuven  Yunger              PHONE NO : 972 77 9084276 
Kibbutz Afek                      SE DECISION MADE: 31-MAY-17
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: IQ Technologies
IQ Technologies Inc.              510(k) NO: K170659(Special)
ATTN: Elli  Josef                 PHONE NO : 702 2608829 
6672 Spencer St., Ste 800         SE DECISION MADE: 26-MAY-17
Las Vegas NV  89119               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
bioMerieux, Inc.                  510(k) NO: K170670(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 31-MAY-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
Medtronic Sofamor Danek           510(k) NO: K170679(Traditional)
ATTN: Kanesha  Hines              PHONE NO : 901 3992670 
1800 Pyramid Place                SE DECISION MADE: 11-MAY-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEVADAPTOR Closed Drug Reconstitution and Transfer System
Teva Medical Ltd., Migada Plant   510(k) NO: K170680(Special)
ATTN: Nadav  Reuben               PHONE NO : 972 4 6908826 
North Industrial Zone             SE DECISION MADE: 16-MAY-17
Kiryat Shmona  IL 10258           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Respire Pink Series with DentiTrac
Respire Medical Holding           510(k) NO: K170692(Traditional)
ATTN: Jonathan  Sandler           PHONE NO : 718 6437326 
18 Bridge Street, Suite 4J        SE DECISION MADE: 26-MAY-17
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenaCure EVLT NeverTouch Direct Introducer Sheath
AngioDynamics, Inc.               510(k) NO: K170695(Traditional)
ATTN: Robin  Fuller               PHONE NO : 508 6587986 
26 Forest Street                  SE DECISION MADE: 30-MAY-17
Marlborough, MA  01752            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLY(TM) Bone Screws
Providence Medical Technology, Inc510(k) NO: K170698(Traditional)
ATTN: Margaret  Wong              PHONE NO : 415 9239376 
1331 N. California Blvd., Suite 32SE DECISION MADE: 31-MAY-17
Walnut Creek CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Iridex TruFocus LIO Premiere
Iridex Corporation                510(k) NO: K170718(Traditional)
ATTN: Gloria  Dy                  PHONE NO : 650 6058807 
1212 Terra Bella Avenue           SE DECISION MADE: 03-MAY-17
Mountain View CA  94043-1824      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScanX Intraoral View
Duerr Dental AG                   510(k) NO: K170733(Traditional)
ATTN: Oliver  Lange               PHONE NO : 49 7142 7050 
Hopfigheimer Strasse 17           SE DECISION MADE: 01-MAY-17
Bietigheim-Bissingen  DE D-74321  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Silk.expert
Cyden Limited                     510(k) NO: K170734(Special)
ATTN: Mike  Kiernan               PHONE NO : 44 1792 485519 
Technium 2, Kings Road, The Docks SE DECISION MADE: 08-MAY-17
Swansea  GB Sa1 8pJ               510(k) STATEMENT
                                                    

DEVICE: GORE VIABIL Short Wire Biliary Endoprosthesis
W.L. Gore & Associates, Inc.      510(k) NO: K170740(Traditional)
ATTN: Barbara L. Smith            PHONE NO : 410 5068189 
301 Airport Road                  SE DECISION MADE: 08-MAY-17
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adhesive Electrodes
Reno Medical Ltd.                 510(k) NO: K170744(Traditional)
ATTN: LiMing  Ren                 PHONE NO : 86 575 82576147 
MNC2246 RM1007, 10/F, Ho King CommSE DECISION MADE: 08-MAY-17
Hongkong  CN 999077               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC Elite
OEC Medical Systems, Inc.         510(k) NO: K170752(Traditional)
ATTN: Helen  Peng                 PHONE NO : 262 4248222 
384 Wright Brothers Drive         SE DECISION MADE: 19-MAY-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 Foot System
Stryker GmbH                      510(k) NO: K170771(Traditional)
ATTN: Paul  Nelson                PHONE NO : 201 8315691 
325 Corporate Drive               SE DECISION MADE: 08-MAY-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bovie J-Plasma Precise FLEX Handpiece
Bovie Medical Corporation         510(k) NO: K170777(Traditional)
ATTN: Rubiela  Maldonado          PHONE NO : 727 8038508 
5115 Ulmerton Road                SE DECISION MADE: 01-MAY-17
Clearwater FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
Terang Nusa Sdn Bhd               510(k) NO: K170779(Special)
ATTN: Robert  Hill                PHONE NO : 60 977 47171 
1 Jalan 8, Pengkalan Chepa 2, InduSE DECISION MADE: 24-MAY-17
Kota Bharu  MY 16100              510(k) STATEMENT
                                                    

DEVICE: PNEUMOCLEAR
W.O.M World Of Medicine GmbH      510(k) NO: K170784(Traditional)
ATTN: Soeren  Markworth           PHONE NO : 011 49 3039981594 
Salzufer 8                        SE DECISION MADE: 15-MAY-17
Berlin  DE 10587                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: In Reach
CurveBeam, LLC                    510(k) NO: K170789(Third Party - Traditional)
ATTN: Stuti  Singh                PHONE NO : 267 4838081 
175 Titus Ave Suite 300           SE DECISION MADE: 05-MAY-17
Warrington PA  18976              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: The Solstice OCT System
Life Spine Inc.                   510(k) NO: K170804(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 18-MAY-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.      510(k) NO: K170828(Abbreviated)
ATTN: Nicole  Bush                PHONE NO : 1 203 4814183 
11 Business Park Drive            SE DECISION MADE: 17-MAY-17
Branford CT  06405                510(k) STATEMENT
                                                    

DEVICE: EpiAccess System
EpiEP, INc                        510(k) NO: K170831(Special)
ATTN: Pamela  Bunes               PHONE NO : 1 434 9510444 
195 Church Street, 17th Floor     SE DECISION MADE: 09-MAY-17
New Haven CT  06510               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAPID Web
Given Imaging Ltd.                510(k) NO: K170839(Traditional)
ATTN: Hilla  Debby                PHONE NO : 972 4 9097774 
2 Hacarmel St New Industrial Park SE DECISION MADE: 26-MAY-17
Yoqneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eko Model E5 System (EME5), Eko DUO
Eko Devices, Inc.                 510(k) NO: K170874(Traditional)
ATTN: Connor  Landgraf            PHONE NO : 1 844 3563384 
2600 10th St, Suite 260           SE DECISION MADE: 19-MAY-17
Berkeley CA  94710                510(k) STATEMENT
                                                    

DEVICE: Mako Partial Knee Application
MAKO Surgical Corp.               510(k) NO: K170891(Traditional)
ATTN: Shikha  Khandelwal          PHONE NO : 201 8316921 
2555 Davie Rd                     SE DECISION MADE: 24-MAY-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
Liofilchem s. r. l.               510(k) NO: K170892(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 25-MAY-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: 27HJ713S
LG Electronics                    510(k) NO: K170899(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 30-MAY-17
Pyeongtaek-si  KR 17709           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PK AIM
Gyrus ACMI Inc.                   510(k) NO: K170908(Traditional)
ATTN: Graham A. L. Baillie        PHONE NO : 508 8042690 
136 Turnpike Road                 SE DECISION MADE: 19-MAY-17
Southborough MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LCD Monitor (MD310C, MD310G, MD210G)
BenQ Corporation                  510(k) NO: K170944(Traditional)
ATTN: Calvin KT Chang             PHONE NO : 886 2 26588880 
16 Jihu Road, Neihu               SE DECISION MADE: 25-MAY-17
Taipei  TW 114                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable ECG Monitor
CONTEC Medical Systems Co.,Ltd    510(k) NO: K170954(Traditional)
ATTN: Xueyong  Li                 PHONE NO : 86 335 8015489 
No.112 Qinhuang West Street, EconoSE DECISION MADE: 30-MAY-17
Qinhuangdao  CN 066004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Televere Digital Imaging System
Televere Systems                  510(k) NO: K170975(Traditional)
ATTN: Randell  Quaal              PHONE NO : 800 3859593 
1160 Cavalier Rd                  SE DECISION MADE: 01-MAY-17
Arnold MD  21012                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURESHOT Distal Targeting System V4.0 Trauma Interface
Smith & Nephew, Inc.              510(k) NO: K170977(Special)
ATTN: Allison  Chan               PHONE NO : 901 3991098 
1450 Brooks Rd                    SE DECISION MADE: 03-MAY-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dymaxeon Spine System
Back 2 Basics Direct, LLC         510(k) NO: K170989(Traditional)
ATTN: Mitchell  Bass              PHONE NO : 216 4475025 
6701 Rockside Road, Suite 200     SE DECISION MADE: 22-MAY-17
Independence OH  44131            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator
Spiration, Inc.                   510(k) NO: K170990(Traditional)
ATTN: Cheryl  Frederick           PHONE NO : 425 6365535 
6675 185th Avenue NE              SE DECISION MADE: 11-MAY-17
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silhouette Featherlift
Silhouette Lift Inc.              510(k) NO: K171005(Special)
ATTN: Anthony  DiBernardo         PHONE NO : 949 7272074 
1 Technology Drive F211           SE DECISION MADE: 03-MAY-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Knotless SutureTak Anchor
Arthrex Inc.                      510(k) NO: K171020(Traditional)
ATTN: David L Rogers              PHONE NO : 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 16-MAY-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ablation Confirmation
NeuWave Medical, Inc.             510(k) NO: K171022(Special)
ATTN: Dan  Kosednar               PHONE NO : 608 5121592 
3529 Anderson Street              SE DECISION MADE: 09-MAY-17
Madison WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nova StatSensor Creatinine Hospital Meter System
Nova Biomedical Corporation       510(k) NO: K171059(Special)
ATTN: Paul W. MacDonald           PHONE NO : 781 6473700 
200 Prospect Street               SE DECISION MADE: 26-MAY-17
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N Latex Cystatin C; N Protein Standard UY
Siemens Healthcare Diagnostics Pro510(k) NO: K171072(Traditional)
ATTN: Christine  Perkins          PHONE NO : 302 6318811 
Emil-von-Behring-Str. 76          SE DECISION MADE: 12-MAY-17
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Video Endoscope System
Zhuhai Pusen Medical Technology Co510(k) NO: K171076(Third Party - Traditional)
ATTN: Wang  ChangShen             PHONE NO : 086 756 6880096 
5/F, Building 1, No 33, Keji San RSE DECISION MADE: 05-MAY-17
Zhuhai  CN 519085                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ALP IFCC Gen.2
Roche Diagnostics Operations (RDO)510(k) NO: K171080(Special)
ATTN: Patrick  Stimart            PHONE NO : 317 5213954 
9115 Hague Road                   SE DECISION MADE: 10-MAY-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guider Catheter Introducer
Rhythm Xience, Inc. (RXI)         510(k) NO: K171081(Third Party - Traditional)
ATTN: James  Hassett              PHONE NO : 952 4797903 
10025 Valley View Road, Suite 130 SE DECISION MADE: 09-MAY-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
Orthofix Inc.                     510(k) NO: K171082(Special)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 05-MAY-17
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iChemVELOCITY Automated Urine Chemistry System
Iris Diagnostics, a Division of Ir510(k) NO: K171083(Traditional)
ATTN: Nancy  Nadler               PHONE NO : 305 3804191 
9172 Eton Avenue                  SE DECISION MADE: 12-MAY-17
Chatsworth CA  91311              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMR40
NeuroLogica Corporation, a Subsidi510(k) NO: K171085(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648503 
Samsung Electronics Co., Ltd 14 ElSE DECISION MADE: 11-MAY-17
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermi Reusable Non-invasive RF Electrode
ThermGen, L.L.C                   510(k) NO: K171094(Traditional)
ATTN: Suzanne  Cheang             PHONE NO : 214 8880683 
8304 Esters Boulevard Suite 890   SE DECISION MADE: 08-MAY-17
Irving TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fujifilm Diathermic Slitter (FlushKnife)
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171096(Special)
ATTN: Jeffrey  Wan                PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 09-MAY-17
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOJAVE Expandable Interbody System
K2M, Inc.                         510(k) NO: K171097(Special)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 10-MAY-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIS Image Management System
Sonomed, Inc.                     510(k) NO: K171098(Third Party - Traditional)
ATTN: Mark  Wallace               PHONE NO : 414 7457870 
1979 Marcus Ave, Suite C105       SE DECISION MADE: 02-MAY-17
New Hyde Park NY  11042           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GM85
Samsung Electronics Co.,Ltd.      510(k) NO: K171119(Traditional)
ATTN: Chulsin  Kim                PHONE NO : 82 31 2007661 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 12-MAY-17
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nucleus Image Management System
NucleusHealth, LLC                510(k) NO: K171130(Third Party - Traditional)
ATTN: Linda  Moore                PHONE NO : 858 5463800 
13280 Evening Creek Dr.           SE DECISION MADE: 04-MAY-17
San Diego CA  91928               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Lipogems System
Lipogems International SpA        510(k) NO: K171135(Traditional)
ATTN: Carlo  Russo                PHONE NO : 39 02 37072408 
viale Bianca Maria 24             SE DECISION MADE: 18-MAY-17
Milano  IT 20129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVS 2430W, EVS 2430GW
DRTECH Corporation                510(k) NO: K171137(Special)
ATTN: Choul-Woo  Shin             PHONE NO : 82 31 7797783 
Suite No. 2, 3 Floor, 29 Dunchon-dSE DECISION MADE: 15-MAY-17
Seongnam-si  KR 13230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation         510(k) NO: K171138(Special)
ATTN: Catherine  Mulcahy          PHONE NO : 315 2346800 
121 Metropolitan Drive            SE DECISION MADE: 17-MAY-17
Liverpool NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LaparoLight Veress Needle
Buffalo Filter, LLC               510(k) NO: K171139(Third Party - Traditional)
ATTN: Kyrylo  Shvetsov            PHONE NO : 716 8357000 
5900 Genesee Street               SE DECISION MADE: 18-MAY-17
Lancaster NY  14086               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc.                      510(k) NO: K171141(Special)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 04-MAY-17
Naples FL  71924                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Universal Neuro III System AXS Screw
Stryker                           510(k) NO: K171152(Special)
ATTN: Jonathan  Schell            PHONE NO : 269 3895596 
750 Trade Centre Way, Suite 200   SE DECISION MADE: 19-MAY-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartByte Device
Scientific Intake                 510(k) NO: K171165(Special)
ATTN: Marc  Gibeley               PHONE NO : 978 6262637 
280 Merrimack Street Suite 503    SE DECISION MADE: 18-MAY-17
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Immunodiagnostic Products Insulin Calibrators
Ortho Clinical Diagnostics        510(k) NO: K171168(Abbreviated)
ATTN: Bradley P. Boyer            PHONE NO : 585 4533421 
100 Indigo Creek Drive            SE DECISION MADE: 16-MAY-17
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Medacta International SA          510(k) NO: K171170(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 25-MAY-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AS-10, CXDI-401RF
Canon, Inc.                       510(k) NO: K171194(Traditional)
ATTN: Shinji  Mori                PHONE NO : 81 3 37582111 
9-1, Imaikami-Cho,Nakahara-Ku     SE DECISION MADE: 24-MAY-17
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
Osprey Medical, Inc.              510(k) NO: K171217(Special)
ATTN: Melanie  Hess               PHONE NO : 952 9558252 
5600 Rowland Road Suite 250       SE DECISION MADE: 26-MAY-17
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DELL UP3017 with QUBYX PerfectLum bundle
Qubyx Software Technologies Inc.  510(k) NO: K171229(Traditional)
ATTN: Marc  Leppla                PHONE NO : 518 6181012 
501 Silverside Road, Suite 105    SE DECISION MADE: 26-MAY-17
Wilmington DE  19809              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: My Dose Coach
Sanofi                            510(k) NO: K171230(Special)
ATTN: Robert  Ezzell              PHONE NO : 617 7101418 
640 Memorial Drive                SE DECISION MADE: 26-MAY-17
Cambridge MA  02142               510(k) STATEMENT
                                                    

DEVICE: Mistral-Air Warming Unit
The Surgical Company International510(k) NO: K171234(Third Party - Special)
ATTN: Kees van Hassel             PHONE NO : 31 033 4507240 
Beeldschermweg 6F                 SE DECISION MADE: 26-MAY-17
Amersfoort  NL 3821 AH            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KARL STORZ ICG Imaging System
Karl Storz Endoscopy- America, Inc510(k) NO: K171238(Special)
ATTN: Winkie  Wong                PHONE NO : 424 2188288 
2151 E. Grand Avenue              SE DECISION MADE: 25-MAY-17
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
Medtronic                         510(k) NO: K171253(Special)
ATTN: Debra  Taitague             PHONE NO : 234 2484186 
1851 East Deere Ave               SE DECISION MADE: 25-MAY-17
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
MicroTherapeutics, Inc. d/b/a ev3 510(k) NO: K171268(Traditional)
ATTN: Eric  Elliott               PHONE NO : 949 2975803 
9775 Toledo Way                   SE DECISION MADE: 31-MAY-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci X Surgical System
Intuitve Surgical, Inc.           510(k) NO: K171294(Special)
ATTN: Brandon  Hansen             PHONE NO : 408 5237485 
1266 Kifer Road                   SE DECISION MADE: 26-MAY-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SutureTape
Arthrex, Inc.                     510(k) NO: K171296(Special)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 26-MAY-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore-S
electroCore, LLC                  510(k) NO: K171306(Special)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 30-MAY-17
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QLAB Advanced Quantification Software
Philips Healthcare                510(k) NO: K171314(Third Party - Traditional)
ATTN: Penny  Greco                PHONE NO : 508 8430282 
3000 Minuteman Rd                 SE DECISION MADE: 30-MAY-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Tyber Medical Wedge System
Tyber Medical LLC                 510(k) NO: K171327(Special)
ATTN: Mark F. Schenk              PHONE NO : 610 8490645 
83 S Commerce Way, Suite 310      SE DECISION MADE: 16-MAY-17
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B R A H M S PCT sensitive KRYPTOR
B.R.A.H.M.S GmbH                  510(k) NO: K171338(Traditional)
ATTN: Sascha  Johannes            PHONE NO : 49 330 2883729 
Neuendorfstr. 25                  SE DECISION MADE: 31-MAY-17
Hennigsdorf  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinpoint GT Needle Guide Kits
C.R. Bard, Inc.                   510(k) NO: K171348(Special)
ATTN: Christopher M. Phillips     PHONE NO : 801 5225965 
650 North 5600 West               SE DECISION MADE: 22-MAY-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surefire Precision Infusion System
Surefire Medical, Inc.            510(k) NO: K171355(Third Party - Special)
ATTN: Lynne  Aronson              PHONE NO : 720 3059877 
6272 W. 91st Avenue               SE DECISION MADE: 17-MAY-17
Westminster CO  80031             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EMS100 Tri-Wave Combination Stimulator
Elite Medical Supply of New York, 510(k) NO: K171387(Special)
ATTN: Jim  Klett                  PHONE NO : 866 7120881___ 
1411 North Batavia Street Suite 11SE DECISION MADE: 31-MAY-17
Orange CA  92867                  510(k) STATEMENT
                                                    

DEVICE: EndoWrist Stapler 45 System and Stapler 45 Reloads
Intuitive Surgical, Inc.          510(k) NO: K171388(Special)
ATTN: Doreen  Nakamura            PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 31-MAY-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


       TOTAL 510(k)s THIS PERIOD   296                                     
       TOTAL WITH SUMMARIES        278                                     
       TOTAL WITH STATEMENTS        18
                                      

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