Medical Devices

June 2017 510(k) Clearances

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


DEVICE: Cerdak Basic
BU POLYSCIENCES EQUIPMENT & TRADIN510(k) NO: K153138(Traditional)
ATTN: N. T. UMAMAHESWARAN         PHONE NO : 301 3255574 
10855 SYMPHONY PARK DR.           SE DECISION MADE: 23-JUN-17
NORTH BETHESDA MD  20852          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless Steel Modular Hand System – MR Conditional, DePuy Synthes Ti-15 Mo Locking Distal Radius Plating System – MR Conditional, DePuy Synthes Hook Plate – MR Conditional, DePuy Synthes Cannulated Titanium Humeral Nail System – MR Conditional, DePuy Synthes Tibial Nail System Ex – MR Conditional, DePuy Synthes LCP® Curved Plates – MR Conditional, DePuy Synthes Elastic Intramedullary Nail (EIN) System – MR Conditional, DePuy Synthes LCP Wrist Fusion Plates – MR Conditional, DePuy Synthes Washer – MR Conditional
SYNTHES (USA) PRODUCTS LLC/DEPUY O510(k) NO: K160553(Traditional)
ATTN: ELIZABETH   JACOBS          PHONE NO : 610 7195768 
1301 GOSHEN PARKWAY               SE DECISION MADE: 30-JUN-17
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulin Algorithms System
INSULIN ALGORITHMS                510(k) NO: K160673(Traditional)
ATTN: Josh   Davidson             PHONE NO : 310 6062055 
9538 W.PICO BLVD. #206            SE DECISION MADE: 07-JUN-17
LOS ANGELES CA  90035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COOK Vacuum Pump
WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K160753(Traditional)
ATTN: Gordana  Pozvek             PHONE NO : 61 738 411188 
95 BRANDL STREET                  SE DECISION MADE: 13-JUN-17
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Howell Biliary Introducer Needle
WILSON-COOK MEDICAL, INC.         510(k) NO: K160890(Traditional)
ATTN: ASHLEY  HOWARD              PHONE NO : 336 7440157 6174
4900 BETHANIA STATION ROAD        SE DECISION MADE: 14-JUN-17
WINSTON-SALEM NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoVa Monitoring System 2
TOSENSE, INC.                     510(k) NO: K160899(Traditional)
ATTN: SUSAN  PEDE                 PHONE NO : 760 5258299 
4225 EXECUTIVE SQUARE SUITE 570   SE DECISION MADE: 22-JUN-17
LA JOLLA CA  92037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axiom PX
ANTHOGYR SAS                      510(k) NO: K161177(Abbreviated)
ATTN: THERESE  CANDAU             PHONE NO : 33 04 50580237 
2237 AVENUE ANDRE LASQUIN         SE DECISION MADE: 15-JUN-17
SALLANCHES  FR 74700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
IMMUNALYSIS CORPORATION           510(k) NO: K161216(Traditional)
ATTN: Joseph  Ginete              PHONE NO : 909 4820840 
829 TOWNE CENTER DRIVE            SE DECISION MADE: 14-JUN-17
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYNTEC HUMERAL NAIL SYSTEM
SYNTEC SCIENTIFIC CORPORATION     510(k) NO: K161327(Traditional)
ATTN: KAVIN  CHU                  PHONE NO : 886 4 7987099 
NO. 2 KUNG SAN ROAD CHUAN SHING INSE DECISION MADE: 08-JUN-17
CHANG HUA  TW 509                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MELODY, Remote Control System for Ultrasound Probe
AdEcho Tech                       510(k) NO: K161354(Traditional)
ATTN: Nicolas   LEFEBVRE          PHONE NO : 33 06 72054018 
7 Rue du Clos Haut de la BouchardiSE DECISION MADE: 12-JUN-17
Naveil  FR 41100                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOVES SLC
THORNHILL RESEARCH INC.           510(k) NO: K161420(Traditional)
ATTN: KIPTON  LADE                PHONE NO : 416 5971325 
210 DUNDAS STREET WEST, SUITE 200 SE DECISION MADE: 06-JUN-17
TORONTO  CA M5G 2E8               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A1C EZ Glycohemoglobin Analysis System
BioHermes Co., Ltd                510(k) NO: K161533(Traditional)
ATTN: Rao  Qiangying              PHONE NO : 86 510 85991708 
2F, 3F, No 136 Mashan Meiliang RoaSE DECISION MADE: 16-JUN-17
Wuxi  CN JS510                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORA Tubing Sets for Hemodialysis
Bain Medical Equipment (Guangzhou)510(k) NO: K161582(Traditional)
ATTN: Sophia  Shao                PHONE NO : 
No. 10 Juncheng Road Eastern Zone SE DECISION MADE: 16-JUN-17
Guangzhou  CN 510760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
SPINAL ANALYTICS & GEOMETRICAL IMP510(k) NO: K161710(Traditional)
ATTN: JAMES J GIBSON              PHONE NO : 813 8150613 
2189 W BUSCH BLVD                 SE DECISION MADE: 29-JUN-17
TAMPA FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solution Set with 1.2 Micron Air Eliminating Filter
Baxter Healthcare Corporation     510(k) NO: K161808(Traditional)
ATTN: John  Lamela                PHONE NO : 224 2702850 
32650 N. Wilson Road              SE DECISION MADE: 21-JUN-17
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CompuFlo Epidural Computer Controlled Anesthesia System
MILESTONE SCIENTIFIC, INC.        510(k) NO: K161883(Traditional)
ATTN: STEPHEN  SOLOMON            PHONE NO : 973 5352717 
220 SOUTH ORANGE AVE.             SE DECISION MADE: 09-JUN-17
LIVINGSTON NJ  07039              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Follicle Aspiration Set
VITROLIFE SWEDEN AB               510(k) NO: K161970(Traditional)
ATTN: ANJA  BENGTZELIUS           PHONE NO : 46 31 7218000 
GUSTAF WERNERS GATA 2             SE DECISION MADE: 14-JUN-17
VASTRA FROLUNDA  SE SE-421 32     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kwart Retro-Inject Ureteral Stent
COOK INCORPORATED                 510(k) NO: K162109(Traditional)
ATTN: KARA  KANORR                PHONE NO : 812 3392235 104072
750 DANIELS WAY                   SE DECISION MADE: 07-JUN-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
SORIN GROUP ITALIA S.R.L          510(k) NO: K162215(Traditional)
ATTN: Luigi  Vecchi               PHONE NO : 11 390 53529811 
86, VIA STATALE 12 NORD           SE DECISION MADE: 16-JUN-17
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spiral Shape Dental Implant System
GP Implants                       510(k) NO: K162299(Traditional)
ATTN: Pivovarov  German           PHONE NO : 972 54 2079520 
Beeri 12A Ap7                     SE DECISION MADE: 22-JUN-17
Netanya  IL                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QT Ultrasound Breast Scanner-1
QT ULTRASOUND LLC                 510(k) NO: K162372(Traditional)
ATTN: ELAINE  IUANOW              PHONE NO : 415 9852091 
3 HAMILTON LANDING SUITE 160      SE DECISION MADE: 06-JUN-17
NOVATO CA  94949                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medcomp Vessel Dilator
MEDCOMP ( MEDICAL COMPONENTS)     510(k) NO: K162389(Traditional)
ATTN: COURTNEY  NIX               PHONE NO : 215 2564201 
1499 DELP DRIVE                   SE DECISION MADE: 01-JUN-17
HARLEYSVILLE PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
MP BIOMEDICALS, LLC               510(k) NO: K162395(Special)
ATTN: STAR  HAN                   PHONE NO : 650 5580395 
1429 ROLLINS ROAD                 SE DECISION MADE: 02-JUN-17
BURLINGAME CA  94010              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuPoint Electrode
MICROPROBES FOR LIFE SCIENCE, INC.510(k) NO: K162459(Traditional)
ATTN: Martin  Bak                 PHONE NO : 301 3309788 
18247-D FLOWER HILL WAY           SE DECISION MADE: 15-JUN-17
Gaithersburg MD  20879            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COSMED K5 Wearable Metabolic Technology
COSMED S.r.l.                     510(k) NO: K162515(Traditional)
ATTN: Andrea  Duca                PHONE NO : 39 06 9315492 
Via dei Piani di Monte Savello, 37SE DECISION MADE: 20-JUN-17
Pavona di Albano Rome  IT 00041   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
Tianjin Empecs Medical Device Co.,510(k) NO: K162564(Traditional)
ATTN: Chae  Chung Lyuel           PHONE NO : 86 22 25695007 
No. 35 And 37, Yingcheng Street, HSE DECISION MADE: 07-JUN-17
Tianjin  CN 300480                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
BIOTECH LUBRICANTS LTD            510(k) NO: K162569(Traditional)
ATTN: Sarah  Brooks               PHONE NO : 44 01730 261224 
TRADEMARK HOUSE, RAMSHILL         SE DECISION MADE: 09-JUN-17
Petersfield  GB GU31 4AT          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NextDent Denture, E-Denture
VERTEX-DENTAL BV                  510(k) NO: K162572(Traditional)
ATTN: O. F. Beckeringh van Loenen PHONE NO : 31 30 6976749 
JOHAN VAN OLDENBARNEVELTLAAN 62   SE DECISION MADE: 30-JUN-17
ZEIST  NL 3705 HJ                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
FISHER & PAYKEL HEALTHCARE        510(k) NO: K162582(Traditional)
ATTN: Tina  O'Brien               PHONE NO : 64 09 5740100 
15 MAURICE PAYKEL PLACE, EAST TAMASE DECISION MADE: 23-JUN-17
AUCKLAND  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Möller Medical Biopsy Needles and Systems
Moller Medical GmbH               510(k) NO: K162588(Traditional)
ATTN: Christoph  Traxler          PHONE NO : 49 661 941950 
Wasserkuppenstrabe 29-31          SE DECISION MADE: 19-JUN-17
Fulda  DE 36043                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEXA Negative Pressure Wound Therapy System
Nexa Medical Ltd.                 510(k) NO: K162610(Traditional)
ATTN: Keith  Heaton               PHONE NO : 011 44 1202238738 
Suite 5-6, Willow View, SouthfieldSE DECISION MADE: 08-JUN-17
Bournemouth  GB BH22 8TR          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
B. BRAUN INTERVENTIONAL SYSTEMS IN510(k) NO: K162625(Traditional)
ATTN: PETER  FLOSDORF             PHONE NO : 610 9974694 
824 TWELFTH AVENUE                SE DECISION MADE: 12-JUN-17
BETHLEHEM PA  18018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iVitri EZ
REPROBITECH CORP.                 510(k) NO: K162640(Traditional)
ATTN: Huai L. Feng                PHONE NO : 516 3016171 
27 HADDON RD                      SE DECISION MADE: 30-JUN-17
New Hyde Park NY  11040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew, Inc. R3™ Constrained Liner
Smith & Nephew, Inc.              510(k) NO: K162641(Traditional)
ATTN: Natalie P. Williams         PHONE NO : 901 3995161 
7135 Goodlett Farms Parkway       SE DECISION MADE: 19-JUN-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Hair Removal System
SHANDONG HUAMEI TECHNOLOGY CO.,LTD510(k) NO: K162659(Traditional)
ATTN: Xu  QingHua                 PHONE NO : 86 536 2110001 
588, CHANGNING ST, HIGH-TECH DISTRSE DECISION MADE: 16-JUN-17
WEIFANG  CN 261000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima Herpes Simplex Viruses 1 & 2 Assay
HOLOGIC, INC.                     510(k) NO: K162673(Traditional)
ATTN: Ron  Domingo                PHONE NO : 858 4108167 
10210 GENETIC CENTER DR.          SE DECISION MADE: 15-JUN-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPro Foot Plating Systems
BIOPRO, INC.                      510(k) NO: K162674(Traditional)
ATTN: AL  LIPPINCOTT              PHONE NO : 810 9827777 
2929 LAPEER ROAD                  SE DECISION MADE: 16-JUN-17
PORT HURON MI  48060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
ROCHE DIAGNOSTICS                 510(k) NO: K162678(Traditional)
ATTN: Kelli  Turner               PHONE NO : 317 5214515 
9115 HAGUE RD.                    SE DECISION MADE: 23-JUN-17
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enobio Wireless EEG
Neuroelectrics Barcelona S.L.U.   510(k) NO: K162681(Traditional)
ATTN: Anna  Maiques               PHONE NO : 0034 93 2540366 
Avenida Tibidabo 47 bis           SE DECISION MADE: 02-JUN-17
Barcelona  ES 08035               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATISSE Anterior Cervical Interbody Fusion Cage System
CTL Medical Corporation           510(k) NO: K162682(Traditional)
ATTN: Tosan  Onosode              PHONE NO : 214 5455820 
4550 Excel Parkway, Suite 300     SE DECISION MADE: 01-JUN-17
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2-Piece Hammertoe Correction System
Life Spine, Inc.                  510(k) NO: K162685(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S. Quality Drive            SE DECISION MADE: 09-JUN-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vibrance Pelvic Trainer
BIOINFINITY (M) SDN. BHD.         510(k) NO: K162689(Traditional)
ATTN: NG SHEA KANG                PHONE NO : 603 6270236 
NO. 21, JALAN 4/62 A, BANDAR MENJASE DECISION MADE: 08-JUN-17
KEPONG  MY 52200                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iTotal® Hip Replacement System
ConforMIS, Inc.                   510(k) NO: K162719(Traditional)
ATTN: Amita  Shah                 PHONE NO : 781 3459164 
28 Crosby Drive                   SE DECISION MADE: 14-JUN-17
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TransFix/EDTA Vacuum Blood Collection Tubes
Caltag Medsystems Ltd.            510(k) NO: K162723(Traditional)
ATTN: Daniel  Harrison            PHONE NO : 011 441280 827460 
Whiteleaf Business Centre, 11 LittSE DECISION MADE: 22-JUN-17
Buckingham  GB MK18 1TF           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
bioMerieux, Inc                   510(k) NO: K162737(Traditional)
ATTN: CHERECE L. JONES            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 21-JUN-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
FUJIFILM Medical Systems U.S.A., I510(k) NO: K162749(Traditional)
ATTN: Shraddha S. More            PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 15-JUN-17
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Picocare
WON TECH CO., LTD.                510(k) NO: K162755(Traditional)
ATTN: James Hoon Lim              PHONE NO : 82 70 78051237 
64, Techno 8-ro, Yuseong-gu       SE DECISION MADE: 12-JUN-17
Daejeon  KR 305-500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KeraStat(R) Gel
KeraNetics, LLC.                  510(k) NO: K162759(Traditional)
ATTN: Luke  Burnett               PHONE NO : 336 7250621 
200 East First Stree, Box #4, SuitSE DECISION MADE: 02-JUN-17
Winston-Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
IMMCO DIAGNOSTICS, INC.           510(k) NO: K162788(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 6910091 
9870 Hollingson Rd                SE DECISION MADE: 19-JUN-17
Clarence NY  14031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gelweave Vascular Grafts
VASCUTEK LTD.                     510(k) NO: K162794(Traditional)
ATTN: NEIL  MCLACHLAN             PHONE NO : 44 141 8125555 
NEWMAINS AVENUE                   SE DECISION MADE: 30-JUN-17
INCHINNAN  GB PA4 9RR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpringTMS
eNeura Inc.                       510(k) NO: K162797(Traditional)
ATTN: Larry W. Getlin             PHONE NO : 408 2456400 
715 North Pastoria Avenue         SE DECISION MADE: 26-JUN-17
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Babyleo TN500
Draegerwerk AG & Co. KGaA         510(k) NO: K162821(Traditional)
ATTN: Bettina  Moebius            PHONE NO : 49 451 8824100 
Moislinger Allee 53-55            SE DECISION MADE: 23-JUN-17
Luebeck  DE 23542                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAMS A1c HA-8180V, CALIBRATOR 80
Arkray Factory, Inc.              510(k) NO: K162822(Traditional)
ATTN: Kazuya  Yorimitsu           PHONE NO : 81 748 866901 
1480 Koji, Konan-cho              SE DECISION MADE: 29-JUN-17
Koka-shi  JP 520-3306             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Encore Neutral
RyMed Technologies, LLC           510(k) NO: K162826(Traditional)
ATTN: Anna  McCutchen             PHONE NO : 512 3017334 
6000 W. William Cannon Drive B300 SE DECISION MADE: 15-JUN-17
Austin TX  78749                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Screws Neoortho
Neoortho Produtos Ortopedicos S/A 510(k) NO: K162874(Traditional)
ATTN: Mariana de Oliveira QuinzaniPHONE NO : 55 41 35351000 
Rus Angelo Domingos Durigan       SE DECISION MADE: 27-JUN-17
Curitiba  BR 82025-100            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEKA MOTUS AX
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K162886(Traditional)
ATTN: PAOLO  PERUZZI              PHONE NO : 39 055 8826807 
VIA BALDANZESE 17                 SE DECISION MADE: 19-JUN-17
CALENZANO  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
BECKMAN COULTER                   510(k) NO: K162897(Traditional)
ATTN: Suzana  Otano               PHONE NO : 305 3802271 
11800 SW 147TH AVE                SE DECISION MADE: 23-JUN-17
MIAMI FL  33196-2500              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin MetaFix Hip Stem
CORIN USA LIMITED                 510(k) NO: K162942(Traditional)
ATTN: RACHEL  KING                PHONE NO : 813 9774469 
5670 W. CYPRESS STREET SUITE C    SE DECISION MADE: 20-JUN-17
TAMPA FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OARtrac System with Patient Specific Reusable Universal PSD Sensors
RADIADYNE, LLC                    510(k) NO: K162954(Traditional)
ATTN: JOHN K. ISHAM               PHONE NO : 281 7599600 
10801 HAMMERLY BLVD., SUITE 220   SE DECISION MADE: 01-JUN-17
HOUSTON TX  77043                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIRA Open Matrix ALIF
CAMBER SPINE TECHNOLOGIES         510(k) NO: K162986(Traditional)
ATTN: Michael  Black              PHONE NO : 855 8999869 
418 E. Lancaster Avenue           SE DECISION MADE: 12-JUN-17
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini Sterilization Wrap
Medline Industries, Inc.          510(k) NO: K162993(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
One Medline Place                 SE DECISION MADE: 23-JUN-17
Mundelein IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INVISIKNOT Ankle Syndesmosis Repair Kit
SMITH & NEPHEW, INC.              510(k) NO: K162996(Traditional)
ATTN: GREGORY  NEAL               PHONE NO : 978 7491000 
150 MINUTEMAN ROAD                SE DECISION MADE: 08-JUN-17
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHA S1 Spinal System
Phamedica, Inc.                   510(k) NO: K163011(Traditional)
ATTN: Henry  Fam                  PHONE NO : 516 4699847 
15 Newtown road                   SE DECISION MADE: 29-JUN-17
Plainview NY  11803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hydris™ Oral Rinse
BIOPHARM CONSULT, L.L.C.          510(k) NO: K163029(Traditional)
ATTN: DAVID S. JOHNSON            PHONE NO : 973 2293731 
5609 HARD ROCK PLACE              SE DECISION MADE: 19-JUN-17
HENRICO VA  23230                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GOLNIT Non-Absorbable PTFE Surgical Suture
Antarma dba Golnit Sutures        510(k) NO: K163049(Traditional)
ATTN: Armine  Badalyan            PHONE NO : 718 2190731 
1204 Avenue U, #2030              SE DECISION MADE: 21-JUN-17
Brooklyn NY  11229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deep Conical (DC) Implants and Accessories
SOUTHERN IMPLANTS (PTY) LTD       510(k) NO: K163060(Traditional)
ATTN: LAURANDA  BREYTENBACH       PHONE NO : 27 12 6671046 
1 ALBERT ROAD                     SE DECISION MADE: 13-JUN-17
IRENE  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
HealthLight, LLC                  510(k) NO: K163079(Traditional)
ATTN: Warren  Graber              PHONE NO : 1 224 2310342 
920 East State Parkway, Suite B   SE DECISION MADE: 13-JUN-17
Schaumburg IL  60173              510(k) STATEMENT
                                                    

DEVICE: Merit Coronary Control Syringe
Merit Medical Systems, Inc.       510(k) NO: K163084(Abbreviated)
ATTN: Cory  Marsh                 PHONE NO : 801 3163690 
1600 West Merit Parkway           SE DECISION MADE: 15-JUN-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terrace™ Anterior Cervical Plate System
CoreLink, LLC                     510(k) NO: K163104(Traditional)
ATTN: Stephan  Jones              PHONE NO : 888 3497808 
7911 Forsyth Blvd, Suite # 200    SE DECISION MADE: 21-JUN-17
St. Louis MO  63105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Livia
LIFECARE LTD.                     510(k) NO: K163153(Traditional)
ATTN: AMNON NAHUM SHARON          PHONE NO : 972 467 16020 
ZIPORI ST.2                       SE DECISION MADE: 28-JUN-17
Tiberias  IL 1424602              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UTF Stem, reduced, #0, #00
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K163193(Traditional)
ATTN: GIMPEL  CHIEN               PHONE NO : 886 3 5773351 2217
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 08-JUN-17
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRIMUS
Carl Zeiss Suzhou Co., Ltd.       510(k) NO: K163195(Traditional)
ATTN: Huang  XiaoDong             PHONE NO : 86 512 82273068 
Modern Indust rial Square 3b No. 3SE DECISION MADE: 21-JUN-17
Suzhou  CN 215126                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parietene DS Composite Mesh
Sofradim Production               510(k) NO: K163212(Traditional)
ATTN: Benjamin  Rochette          PHONE NO : 33 4 74089000 
116 avenue du Formans             SE DECISION MADE: 29-JUN-17
Trevoux  FR 01600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinpoint GT Needles
C.R. Bard, Inc.                   510(k) NO: K163216(Traditional)
ATTN: Silvia  De La Barra         PHONE NO : 801 5225909 
605 North 5600 West               SE DECISION MADE: 27-JUN-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APVolution System
AESTHETIC-PRESS, LLC              510(k) NO: K163228(Abbreviated)
ATTN: Jorg  Muller                PHONE NO : 415 6925372 
6613 STATE ROAD 54                SE DECISION MADE: 05-JUN-17
NEW PORT RICHEY FL  34653         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K163313(Traditional)
ATTN: Kevin  Mader                PHONE NO : 319 2487777 
(D/B/A CIVCO MEDICAL SOLUTIONS) 6 SE DECISION MADE: 09-JUN-17
Deep River CT  06417              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
CAREFUSION 303, INC.              510(k) NO: K163316(Traditional)
ATTN: Erika  Fernandez            PHONE NO : 847 3628097 
75 N Fairway Drive                SE DECISION MADE: 22-JUN-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiDCOunity v2 Hemodynamic Monitor
LiDCO Ltd                         510(k) NO: K163334(Traditional)
ATTN: JI HEE KO                   PHONE NO : 44 20 77491500 
16 ORSMAN ROAD                    SE DECISION MADE: 05-JUN-17
LONDON  GB N1 5QJ                 510(k) STATEMENT
                                                    

DEVICE: TVC Imaging System, TVC Catheter
Infraredx, Inc.                   510(k) NO: K163345(Traditional)
ATTN: Stephen  Sum                PHONE NO : 781 3459651 
34 Third Avenue                   SE DECISION MADE: 21-JUN-17
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneTouch Via On-Demand Insulin Delivery System
LifeScan Europe, a division of Cil510(k) NO: K163357(Traditional)
ATTN: Kirsten  Franco             PHONE NO : 484 3286043 
Gubelstrasse 34                   SE DECISION MADE: 07-JUN-17
Zug  CH CH-6300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR Hybrid Glenoid System
Limacorporate S.p.A.              510(k) NO: K163397(Traditional)
ATTN: Michela  Zanotto            PHONE NO : 39 0432 945511 
via Nazionale 52                  SE DECISION MADE: 29-JUN-17
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tria Firm Ureteral Stent
Boston Scientific Corporation     510(k) NO: K163399(Traditional)
ATTN: Christine  Shoemaker        PHONE NO : 508 6834214 
100 Boston Scientific Way         SE DECISION MADE: 22-JUN-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
Girgis Scope LLC                  510(k) NO: K163412(Traditional)
ATTN: Madgy S. Girgis             PHONE NO : 732 7109724 
2 Stonegate Drive                 SE DECISION MADE: 22-JUN-17
Monroe Township NJ  08831         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraScore Focused Force PTA Balloon
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K163420(Traditional)
ATTN: TIMOTHY  WADE               PHONE NO : 480 6382939 
1625 WEST 3RD ST                  SE DECISION MADE: 14-JUN-17
TEMPE AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stellar LEAP
PDG Product Design Group, Inc     510(k) NO: K163432(Traditional)
ATTN: Torr  Brown                 PHONE NO : 604 3266644 
103 - 318 East Kent Ave. South    SE DECISION MADE: 27-JUN-17
Vancouver  CA V5X4NC              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hypodermic Pinpoint™ GT Needle
C. R. Bard, Inc.                  510(k) NO: K163437(Traditional)
ATTN: Jamie  Howell               PHONE NO : 801 5225465 
605 North 5600 West               SE DECISION MADE: 23-JUN-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premium Plus Disposable Barrier Sleeve
PREMIUM PLUS INTERNATIONAL LIMITED510(k) NO: K163447(Traditional)
ATTN: JESSICA  MAO                PHONE NO : 852 276 13211 
FLAT 1001 YUEN LONG TRADING CENTRESE DECISION MADE: 20-JUN-17
HONG KONG  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyPHo Laser System
Hyper Photonics SRL               510(k) NO: K163449(Third Party - Traditional)
ATTN: Isabella  Carrer            PHONE NO : 39 039 89086512 
Via Lecco 61                      SE DECISION MADE: 23-JUN-17
Vimercate MB  IT 20871            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: C-Line Orthodontic Ceramic Bracket
BIOCETEC CO., LTD                 510(k) NO: K163467(Traditional)
ATTN: DAVE  KIM                   PHONE NO : 82 2 7042876 
RM 3-952AB, H1-DONG, KIST,5, HWARASE DECISION MADE: 14-JUN-17
SEOUL  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Galvanic Spa, Model: SKB-1405
ShenZhen Siken 3D Technology Devel510(k) NO: K163470(Traditional)
ATTN: Kimi  Xue                   PHONE NO : 0755 27 697523 
Siken Industrial Park, East AvenueSE DECISION MADE: 02-JUN-17
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iVue
Optovue, Inc.                     510(k) NO: K163475(Traditional)
ATTN: Edward J. Sinclair          PHONE NO : 510 6238868 
2800 Bayview Drive                SE DECISION MADE: 09-JUN-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Summit Spine Channel Cervical Interbody Fusion System
Summit Spine                      510(k) NO: K163494(Traditional)
ATTN: Eric  Buescher              PHONE NO : 877 2089272 
2333 Airport Rd.                  SE DECISION MADE: 20-JUN-17
Georgetown TX  78628              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
Vertera, Inc.                     510(k) NO: K163506(Traditional)
ATTN: Wei Allen Chang             PHONE NO : 571 7583783 
739 Trabert Ave. NW Suite F       SE DECISION MADE: 19-JUN-17
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zio AT ECG Monitoring System
IRHYTHM TECHNOLOGIES, INC.        510(k) NO: K163512(Traditional)
ATTN: RICH  LAGUNA                PHONE NO : 415 6325700 
650 TOWNSEND STREET SUITE 380     SE DECISION MADE: 02-JUN-17
SAN FRANCISCO CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vessel Dilator
Fetzer Medical GmbH & Co. KG      510(k) NO: K163524(Traditional)
ATTN: Harald  Jung                PHONE NO : 49 7462 94799182 
Unter Buchsteig 5                 SE DECISION MADE: 29-JUN-17
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Perfusion System 1
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K163531(Traditional)
ATTN: BRYAN  HANN                 PHONE NO : 734 7415816 
6200 JACKSON ROAD                 SE DECISION MADE: 07-JUN-17
ANN ARBOR MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASD Oral Appliances
AMERICAN SLEEP DENTISTRY          510(k) NO: K163580(Traditional)
ATTN: RYAN  GREGERSON             PHONE NO : 800 5551518 
1957 WEST ROYAL HUNTE DRIVE STE 25SE DECISION MADE: 08-JUN-17
CEDAR CITY UT  84720-1903         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Orthopedics Total Hip Arthroplasty System
Responsive Orthopedics, LLC       510(k) NO: K163585(Traditional)
ATTN: Kathy  Remsen               PHONE NO : 844 8225576 
5865 E State Road 14              SE DECISION MADE: 02-JUN-17
Columbia City IN  46725           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Additive Orthopaedics Bunion System
Additive Orthopaedics, LLC.       510(k) NO: K163593(Traditional)
ATTN: Gregory  Kowalczyk          PHONE NO : 732 8826633 
83 Amelia Circle                  SE DECISION MADE: 20-JUN-17
Little Silver NJ  07739           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
Guangzhou Jinxinbao Electronic Co.510(k) NO: K163603(Traditional)
ATTN: Mowu  Zhu                   PHONE NO : 86 020 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 06-JUN-17
Guangzhou  CN 511470              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
PALL INTERNATIONAL SARL           510(k) NO: K163609(Traditional)
ATTN: Karen  Peterson-Doyle       PHONE NO : 516 8019267 
AVENUE DE TIVOLI 3                SE DECISION MADE: 01-JUN-17
Fribourg  CH CH-1700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
FUJIFILM Medical Systems U.S.A., I510(k) NO: K163624(Traditional)
ATTN: Dharaben  Desai             PHONE NO : 1 203 2763445 
419 West Avenue                   SE DECISION MADE: 30-JUN-17
Stamford CT  06902                510(k) STATEMENT
                                                    

DEVICE: Katalyst Cyclophotocoagulation Probe
Katalyst Surgical, LLC            510(k) NO: K163632(Traditional)
ATTN: Meryl  Koch                 PHONE NO : 636 5365950 
754 Goddard Avenue                SE DECISION MADE: 15-JUN-17
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePlex Respiratory Pathogen Panel
GENMARK DIAGNOSTICS, INCORPORATED 510(k) NO: K163636(Traditional)
ATTN: ALAN  MADERAZO              PHONE NO : 760 4484308 
5964 LA PLACE COURT               SE DECISION MADE: 09-JUN-17
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LS-5 ePTFE Suture
LSI SOLUTIONS                     510(k) NO: K163639(Traditional)
ATTN: Kevin  Bentley              PHONE NO : 585 8696669 
7796 VICTOR-MENDON RD             SE DECISION MADE: 02-JUN-17
VICTOR NY  14564                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ePlex Instrument
GenMark Diagnostics, Incorporated 510(k) NO: K163652(Traditional)
ATTN: Alan  Maderazo              PHONE NO : 760 4484308 
5964 La Place Court               SE DECISION MADE: 09-JUN-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUITESTENSA
EBIT srl                          510(k) NO: K163668(Traditional)
ATTN: Marco  Fruscione            PHONE NO : 39 010 6547476 
Via Melen 77                      SE DECISION MADE: 23-JUN-17
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silhouette InstaLift
SILHOUETTE LIFT, INC.             510(k) NO: K163676(Traditional)
ATTN: DOUG  ABEL                  PHONE NO : 978 6211139 
1 TECHNOLOGY DRIVE SUITE F211     SE DECISION MADE: 16-JUN-17
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Automatic Blood Pressure Monitor MD3600
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K163679(Traditional)
ATTN: Patrick  Chow               PHONE NO : 852 28 516789 
Block 7, Zhu Keng Industrial Zone,SE DECISION MADE: 07-JUN-17
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.             510(k) NO: K170001(Traditional)
ATTN: James A. Bonafini, Jr.      PHONE NO : 585 4589409 
1667 Lake Avenue, Suite 354       SE DECISION MADE: 02-JUN-17
Rochester NY  14615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Fistula Plug
Cook Biotech Incorporated         510(k) NO: K170016(Traditional)
ATTN: Perry W Guinn               PHONE NO : 765 4973355 
1425 Innovation Place             SE DECISION MADE: 21-JUN-17
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiopaque Tissue Marker
Viscus Biologics, LLC             510(k) NO: K170026(Traditional)
ATTN: Leslie Rebecca Clark        PHONE NO : 216 7442740 
10000 Cedar Ave                   SE DECISION MADE: 02-JUN-17
Cleveland OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERRAD VELOCITY Biological Indictator and Reader
Advanced Sterilization Products (A510(k) NO: K170039(Traditional)
ATTN: Sun  Choi                   PHONE NO : 949 4536378 
33 Technology Drive               SE DECISION MADE: 20-JUN-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K170044(Traditional)
ATTN: MARIA E. WAGNER             PHONE NO : 
2212 DUPONT DR.                   SE DECISION MADE: 06-JUN-17
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swedge™ Pedicle Screw Fixation System
Spinal Resources, Inc.            510(k) NO: K170045(Traditional)
ATTN: Bernard  Bedor              PHONE NO : 904 5409049 
5450 NW. 33rd Ave. Unit 103       SE DECISION MADE: 26-JUN-17
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green16/Green18 (Model: PHT-65LHS)
VATECH CO., LTD.                  510(k) NO: K170066(Traditional)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799585 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 16-JUN-17
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
Viet Glove Corporation            510(k) NO: K170094(Traditional)
ATTN: Pham Ngoc Thanh             PHONE NO : 84 0650 591220 
Cau Sat Hamlet, Lai Hung Commune BSE DECISION MADE: 23-JUN-17
Bau Bang Province  VN             510(k) STATEMENT
                                                    

DEVICE: Valiant Curing Light
Inter-Med / Vista Dental Products 510(k) NO: K170101(Traditional)
ATTN: Alex  Johnson               PHONE NO : 262 6335902 
2200 South St. Ste. A             SE DECISION MADE: 08-JUN-17
Racine WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta III Lithotripter
Dornier MedTech America           510(k) NO: K170122(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts blvd                 SE DECISION MADE: 28-JUN-17
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynamic Coronary Roadmap
Philips Medical Systems Nederland 510(k) NO: K170130(Abbreviated)
ATTN: Elaine  Alan                PHONE NO : 1 978 4393357 
Veenpluis 4-6                     SE DECISION MADE: 02-JUN-17
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StentBoost Live
Philips Medical Stystems Nederland510(k) NO: K170144(Abbreviated)
ATTN: Elaine  Alan                PHONE NO : 1 858 7641281 
Veenpluis 4-6                     SE DECISION MADE: 07-JUN-17
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EK12 Algorithm
GE Medical Systems Information Tec510(k) NO: K170155(Traditional)
ATTN: Amy  Yang                   PHONE NO : 414 7213807 
9900 West Innovation Drive        SE DECISION MADE: 06-JUN-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerGlide ST Midline Catheter
C. R. Bard, Inc.                  510(k) NO: K170158(Traditional)
ATTN: JACOB  LEE                  PHONE NO : 801 5225823 
605 North 5600 West               SE DECISION MADE: 01-JUN-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE Intramedullary Limb Lengthening System
NuVasive Specialized Orthopedics, 510(k) NO: K170169(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 5446478 
101 Enterprise, Suite 100         SE DECISION MADE: 09-JUN-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
Toshiba Medical Systems Corporatio510(k) NO: K170177(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 30-JUN-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
MEDTRONIC VASCULAR, INC.          510(k) NO: K170191(Special)
ATTN: AARON  HAGE                 PHONE NO : 763 3987000 
3033 CAMPUS DRIVE                 SE DECISION MADE: 16-JUN-17
PLYMOUTH MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
Cardinal Health, Inc.             510(k) NO: K170198(Traditional)
ATTN: Megan  Middaugh             PHONE NO : 847 8876812 
1500 Waukegan Road                SE DECISION MADE: 15-JUN-17
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carbon Dioxide Reagent Set
Teco Diagnostics, Inc.            510(k) NO: K170200(Traditional)
ATTN: Hyun Bin Song               PHONE NO : 714 4631111 
1268 North Lakeview Avenue        SE DECISION MADE: 01-JUN-17
Anaheim CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: System, Applicator, Radionuclide, Remote Controlled
Kobold, LLC                       510(k) NO: K170203(Traditional)
ATTN: Deanna  Hughes              PHONE NO : 818 3210116 
23403 E. Mission Ave. Suite 220E  SE DECISION MADE: 01-JUN-17
Liberty Lake WA  99019            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SupraSDRM Biodegradable Matrix Wound Dressing
PolyMedics Innovations GmbH       510(k) NO: K170213(Traditional)
ATTN: Kenneth K. Kleinhenz        PHONE NO : 858 3447143 
Heerweg 15D                       SE DECISION MADE: 28-JUN-17
Denkendorf  DE 73770              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BodyTom Elite
NeuroLogica Corporation, a Subsidi510(k) NO: K170238(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648503 
14 Electronics Avenue             SE DECISION MADE: 14-JUN-17
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRAVITY™ Syndesmosis LP
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K170249(Traditional)
ATTN: MICHAEL  MULLINS            PHONE NO : 901 8674142 
1023 CHERRY ROAD                  SE DECISION MADE: 30-JUN-17
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartTarget
SmartTarget, Ltd.                 510(k) NO: K170250(Third Party - Traditional)
ATTN: Dean  Barratt               PHONE NO : 44 020 79932390 
The Network Building (c/o UCL BusiSE DECISION MADE: 07-JUN-17
London  GB W1T 4TP                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AcuNav Diagnostic Ultrasound Catheter 8F,10F
Siemens Medical Solutions USA, Inc510(k) NO: K170263(Special)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 15-JUN-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
LS Scientific Inc. D.B.A. KSE Scie510(k) NO: K170270(Traditional)
ATTN: Jordan  Reynolds            PHONE NO : 919 5973500 
2714 South Miami Boulevard        SE DECISION MADE: 23-JUN-17
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
MicroPort Orthopedics, Inc.       510(k) NO: K170288(Traditional)
ATTN: Grace  Johnson-Bann         PHONE NO : 901 2905904 
5677 Airline Road                 SE DECISION MADE: 15-JUN-17
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tranquil Interbody System
Nexus Spine, LLC                  510(k) NO: K170297(Traditional)
ATTN: Jared  Crocker              PHONE NO : 801 7028342 
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 27-JUN-17
Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ion PGM Dx System
LIFE TECHNOLOGIES CORPORATION     510(k) NO: K170299(Traditional)
ATTN: EMILY  FINNEGAN             PHONE NO : 916 8380714 
5781 VAN ALLEN WAY                SE DECISION MADE: 22-JUN-17
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YELLOW LASER PHOTOCOAGULATOR YLC-500
NIDEK CO., LTD.                   510(k) NO: K170302(Traditional)
ATTN: Yoneji  Mizuno              PHONE NO : 81 533 678901 
34-14 Maehama, Hiroishicho        SE DECISION MADE: 23-JUN-17
Gamagori  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Agilis NxT Steerable Introducer
Innovative Health, LLC.           510(k) NO: K170311(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5255972 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 02-JUN-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECRET RF
Ilooda Co., Ltd.                  510(k) NO: K170325(Traditional)
ATTN: Yun Jung Ha                 PHONE NO : 82 263 662124 
120, Jangan-ro 458 Beon-gil JanganSE DECISION MADE: 13-JUN-17
Suwon-Si  KR 100-85816200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Variobase Abutments
Institut Straumann AG             510(k) NO: K170354(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 619 651260 
Peter Merian Weg 12               SE DECISION MADE: 07-JUN-17
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Variobase Abutments
Institut Straumann AG             510(k) NO: K170356(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 619 651260 
Peter Merian Weg 12               SE DECISION MADE: 07-JUN-17
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Peripherals, LLC Family of Bare Laser Fibers
Laser Peripherals, LLC            510(k) NO: K170366(Traditional)
ATTN: Jeff  Stein                 PHONE NO : 763 5258483 
13355 10th Ave, Suite 110         SE DECISION MADE: 08-JUN-17
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpiralTech Dental Implant System
SpiralTech Superior Dental Implant510(k) NO: K170372(Traditional)
ATTN: Daniel  Rosenthal           PHONE NO : 
875 N Michigan Avenue, Suite 3106 SE DECISION MADE: 30-JUN-17
Chicago IL  60611                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoBook Series Diagnostic Ultrasound System
CHISON Medical Imaging Co., Ltd.  510(k) NO: K170374(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 86 510 85311707 
NO.228, ChangJiang East Road,BlockSE DECISION MADE: 06-JUN-17
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Talos® Lumbar (HA) PEEK IBF Devices
Meditech Spine, LLC               510(k) NO: K170395(Traditional)
ATTN: Bruce  Dunaway              PHONE NO : 678 9745287 
1447 Peachtree St NE Suite 440    SE DECISION MADE: 02-JUN-17
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Vida
Siemens Medical Solutions USA, Inc510(k) NO: K170396(Traditional)
ATTN: Cordell L. Fields, Esq.     PHONE NO : 610 4486469 
65 Valley Stream Parkway Mailcode SE DECISION MADE: 14-JUN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Titan 1.5T, MRT-1510, M-Power GX
Toshiba Medical Systems Corporatio510(k) NO: K170412(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 07-JUN-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
Lin-Zhi International, Inc.       510(k) NO: K170416(Traditional)
ATTN: Bernice  Lin                PHONE NO : 408 9708811 
2945 Oakmead Village Court        SE DECISION MADE: 26-JUN-17
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker SonicPin System
Stryker Trauma Gmbh               510(k) NO: K170418(Traditional)
ATTN: Heike  Gustke               PHONE NO : 49 434 8702637 
Prof-Kuentscher-Str. 1-5          SE DECISION MADE: 20-JUN-17
Schoenkirchen  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ElectroTek
MobileMedTek                      510(k) NO: K170441(Traditional)
ATTN: Bryan  Ehret                PHONE NO : 502 6443827 
1205 E. Washington St., Ste 115   SE DECISION MADE: 05-JUN-17
Louisville KY  40206              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROCOTYL® PRIME Acetabular Cup System
MicroPort Orthopedics Inc         510(k) NO: K170444(Traditional)
ATTN: Kaitlin  Grove              PHONE NO : 901 8674162 
5677 Airline Road                 SE DECISION MADE: 26-JUN-17
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Small Fragment Lower Extremity Plates
Smith & Nephew, Inc.              510(k) NO: K170457(Traditional)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 14-JUN-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sorin Connect
Sorin Group Deutschland GmbH      510(k) NO: K170460(Special)
ATTN: Luigi  Vecchi               PHONE NO : 39 0535 29811 
Lindberghstrasse, 25              SE DECISION MADE: 08-JUN-17
Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
Innovative Health, LLC.           510(k) NO: K170474(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 16-JUN-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celesteion, PCA-9000A/3
Toshiba Medical Systems Corporatio510(k) NO: K170490(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 01-JUN-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: sensiLift
EL GLOBAL TRADE LTD               510(k) NO: K170499(Traditional)
ATTN: Yael  Liebes-Peer           PHONE NO : 972 9 7889067 
8 Tzoran St, P.O. Box 8242        SE DECISION MADE: 15-JUN-17
Netanya  IL 4250608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Nitrile Surgical Gloves, Powder-free
Primus Gloves PVT Limited         510(k) NO: K170515(Traditional)
ATTN: Jose  Paul M                PHONE NO : 91 484 2413063 
Plot No 14A, Cochin Special EconomSE DECISION MADE: 09-JUN-17
Cochin  IN 682037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImPACT Quick Test
ImPACT Applications, Inc.         510(k) NO: K170551(Traditional)
ATTN: Michael  Zagorski           PHONE NO : 412 5678400 939
9665 Granite Ridge Drive, Suite 55SE DECISION MADE: 21-JUN-17
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioLogs ECG Analysis Platform
Cardiologs Technologies           510(k) NO: K170568(Traditional)
ATTN: Quentin de Snoeck           PHONE NO : 33 144 278035 
15 rue I'Ecole de Medecine        SE DECISION MADE: 26-JUN-17
Paris  FR 75006                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Shoreline ACS - Anterior Cervical Standalone System
SeaSpine Orthopedics Corporation  510(k) NO: K170569(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 15-JUN-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
Tyber Medical, LLC                510(k) NO: K170571(Traditional)
ATTN: Mark F. Schenk              PHONE NO : 610 8490645 
83 S Commerce Way, Suite 310      SE DECISION MADE: 20-JUN-17
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altomed Malhotra Platinum Segments
Altomed Limited                   510(k) NO: K170591(Traditional)
ATTN: Stuart  March               PHONE NO : 11 441 915190111 
2 Whitney Way Bolden Business ParkSE DECISION MADE: 06-JUN-17
Bolden, Tyne and Wear  GB ne35 9pe510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Continuous Single Culture-NX Complete (CSCM-NXC)
Irvine Scientific Sales Co., Inc. 510(k) NO: K170602(Traditional)
ATTN: Jayme  Yamaguchi-Owens      PHONE NO : 800 4375706 254
2511 Daimler Street               SE DECISION MADE: 07-JUN-17
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReBOSSIS85
ORTHOREBIRTH Co., Ltd.            510(k) NO: K170620(Traditional)
ATTN: Yasutoshi  Nishikawa        PHONE NO : 81 4 55323650 
3-17-43 Chigasaki Higashi         SE DECISION MADE: 23-JUN-17
Tsuzuki-ku Yokohama  JP 224-0033  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITRUVIAN INFILTRATION PUMP
Black & Black Surgical, Inc.      510(k) NO: K170629(Third Party - Traditional)
ATTN: CYNTHIA  REES               PHONE NO : 770 4144880 
5238 Royal Woods Pkwy Suite 170   SE DECISION MADE: 22-JUN-17
Tucker GA  30084                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Retina Workplace
Carl Zeiss Meditec AG             510(k) NO: K170638(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 3641 220301 
Goeschwitzer strasse 51-52        SE DECISION MADE: 21-JUN-17
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARCHITECT B.R.A.H.M.S PCT,  ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
Fisher Diagnostics                510(k) NO: K170652(Traditional)
ATTN: Connie  Yang                PHONE NO : 540 8683603 
8365 Valley Pike                  SE DECISION MADE: 01-JUN-17
Middletown VA  22645              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zepto
Mynosys Cellular Devices, Inc.    510(k) NO: K170655(Traditional)
ATTN: Dan  Marinsik               PHONE NO : 510 8576296 
46710 Fremont Blvd.               SE DECISION MADE: 02-JUN-17
Fremont CA  94538-6538            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reinforced Flexible Collagen Nerve Cuff
Collagen Matrix, Inc.             510(k) NO: K170656(Traditional)
ATTN: Peggy  Hansen               PHONE NO : 1 201 4051477 
15 Thornton Road                  SE DECISION MADE: 01-JUN-17
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Novosyn Quick Absorbable Suture
Aesculap, Inc.                    510(k) NO: K170661(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 1 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 08-JUN-17
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulia Diabetes Management Companion
Voluntis S.A.                     510(k) NO: K170669(Traditional)
ATTN: Raffi  Krikorian            PHONE NO : 33 141 383920 
58, Avenue de Wagram              SE DECISION MADE: 19-JUN-17
Paris  FR 75017                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Continuous Single Culture -NX (CSCM-NX)
Irvine Scientific Sales Co., Inc. 510(k) NO: K170681(Traditional)
ATTN: Jayme  Yamaguchi-Owens      PHONE NO : 800 4375706 254
2511 Daimler Street               SE DECISION MADE: 08-JUN-17
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Firebow Wire Torque Assist Device
Vesatek, LLC                      510(k) NO: K170684(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 29-JUN-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flower Bone Screw Set
Flower Orthopedics Corporation    510(k) NO: K170687(Special)
ATTN: Jessica  Huang              PHONE NO : 215 3234018 
100 Witmer Road. Suite 280        SE DECISION MADE: 06-JUN-17
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phantom Small Bone Intramedullary Nail System
Paragon 28, Inc.                  510(k) NO: K170693(Traditional)
ATTN: Frank S. Bono               PHONE NO : 888 7281888 
4B Inverness Ct. E., STE 280      SE DECISION MADE: 19-JUN-17
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OWL RF INSULATED CANNULAE
Diros Technology Inc.             510(k) NO: K170708(Special)
ATTN: Ron  Baker                  PHONE NO : 905 4153440 
120 Gibson Drive                  SE DECISION MADE: 27-JUN-17
Markham  CA L3R 2Z3               510(k) STATEMENT
                                                    

DEVICE: CURVE Laser System
YOLO Medical, Inc.                510(k) NO: K170709(Traditional)
ATTN: Robert  Krznaric            PHONE NO : 604 5422200 
1959 152nd Street, Suite 245      SE DECISION MADE: 06-JUN-17
Surrey  CA v4a 9e3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
Zimmer GmbH                       510(k) NO: K170711(Traditional)
ATTN: Roberto  Tommasini          PHONE NO : 41 58 8548264 
Sulzerallee 8                     SE DECISION MADE: 01-JUN-17
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc           510(k) NO: K170713(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 13-JUN-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue
GE Medical Systems Ultrasound & Pr510(k) NO: K170714(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 21-JUN-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biopsy Forceps
Fehling Instruments GmbH & Co. KG 510(k) NO: K170726(Traditional)
ATTN: Ulrike  Lindner             PHONE NO : 49 6188 95740 
Hanauer Landstr. 7A               SE DECISION MADE: 02-JUN-17
Karlstein  DE D-63791             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 Compression Plating System
Stryker GmbH                      510(k) NO: K170727(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 8316365 
325 Corporate Drive               SE DECISION MADE: 22-JUN-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E. HISTOLYTICA QUIK CHEK
TECHLAB, Inc.                     510(k) NO: K170728(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 07-JUN-17
Blacksburg VA  24060-6358         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ System, including JAZZ Band
Implanet, S.A.                    510(k) NO: K170730(Traditional)
ATTN: Fabienne Larquey Cadiere    PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 09-JUN-17
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Clear Vinyl Patient Examination Gloves
Zibo Yue Fan Medical Products Co, 510(k) NO: K170735(Traditional)
ATTN: Wu  Xiaoli                  PHONE NO : 86 053 37527018 
No.108 Wanjie Road. Yuqiao IndustrSE DECISION MADE: 27-JUN-17
Zibo  CN 255000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HySil Impression Materials
Osstem Implant Co., Ltd..         510(k) NO: K170736(Traditional)
ATTN: Heekwon  Son                PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 07-JUN-17
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GTK Disposable Needle Guides
GEOTEK Medikal Ltd Sti            510(k) NO: K170741(Traditional)
ATTN: Latif  Iba                  PHONE NO : 90 312 3959852 
Ivedik OSB, Agac Metal Sitesi 1436SE DECISION MADE: 01-JUN-17
Ankara  TR 06738                  510(k) STATEMENT
                                                    

DEVICE: syngo Application Software
Siemens Medical Solutions, USA, In510(k) NO: K170747(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 09-JUN-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRIdian Linac System with 138-leaf Collimator
ViewRay Incorporated              510(k) NO: K170751(Traditional)
ATTN: Sean  Delaney               PHONE NO : 650 2520969 
2 Thermo Fisher Way               SE DECISION MADE: 07-JUN-17
Oakwood Village OH  44146         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc.           510(k) NO: K170755(Traditional)
ATTN: Victoria  Wheeler           PHONE NO : 585 6278706 
150 Verona Street                 SE DECISION MADE: 21-JUN-17
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRE Pulmonary Balloon Dilatation Catheter
Boston Scientific Corporation     510(k) NO: K170759(Special)
ATTN: Jia  Huang                  PHONE NO : 508 6834360 
100 Boston Scientific Way         SE DECISION MADE: 23-JUN-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Non-Reinforced Surgical Gown
Cardinal Health 200, LLC          510(k) NO: K170762(Traditional)
ATTN: Caroline  Miceli            PHONE NO : 847 8876864 
1500 Waukegan Road                SE DECISION MADE: 09-JUN-17
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
ACell, Inc.                       510(k) NO: K170763(Traditional)
ATTN: Salman  Elmi                PHONE NO : 410 9538500 
6640 Eli Whitney Drive            SE DECISION MADE: 08-JUN-17
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
Liofilchem s.r.l.                 510(k) NO: K170772(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 07-JUN-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc.      510(k) NO: K170792(Special)
ATTN: Kara  Cutshall              PHONE NO : 651 2024886 
1225 Old Highway 8 NW             SE DECISION MADE: 09-JUN-17
Saint Paul MN  55112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
HARTALEGA NGC SDN. BHD.           510(k) NO: K170794(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 603 6 2771733 
No.1 Persiaran Tanjung Kawasan PerSE DECISION MADE: 30-JUN-17
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: HydroMARK Breast Biopsy Site Markers
Devicor Medical Products, Inc.    510(k) NO: K170803(Traditional)
ATTN: Shawna  Rose                PHONE NO : 513 8649178 
300 E-Business Way, Fifth Floor   SE DECISION MADE: 15-JUN-17
Cincinnati OH  45241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTUNE Cemented Tibial Base, Fixed Bearing
DePuy (Ireland)                   510(k) NO: K170806(Traditional)
ATTN: Carol S. Ming               PHONE NO : 1 508 9776448 
Loughbeg Ringaskiddy              SE DECISION MADE: 15-JUN-17
Co. Cork Munster  IE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halcyon
Varian Medical Systems Inc.       510(k) NO: K170817(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 27-JUN-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
Choice Spine, LP                  510(k) NO: K170821(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 08-JUN-17
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K170823(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 12-JUN-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unison-C Anterior Cervical Fixation System
Pioneer Surgical Technology, Inc. 510(k) NO: K170830(Traditional)
ATTN: Sarah  Pleaugh              PHONE NO : 906 2269909 
375 River Park Circle             SE DECISION MADE: 28-JUN-17
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alians Fragment Specific
Newclip Technics                  510(k) NO: K170843(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 16-JUN-17
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and 510(k) NO: K170847(Traditional)
ATTN: Renee  Webb                 PHONE NO : 1 847 2776078 
9900 Innovation Drive             SE DECISION MADE: 14-JUN-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alzair Allergy Blocker
Nasaleze International Ltd        510(k) NO: K170848(Traditional)
ATTN: Matt  Duxbury               PHONE NO : 44 016 24611050 
Old Castletown Road               SE DECISION MADE: 14-JUN-17
Douglas  IM Im2 1qa               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIMPLANT Guide
Dentsply Sirona                   510(k) NO: K170849(Traditional)
ATTN: Helen  Lewis                PHONE NO : 717 8471332 
221 West Philadelphia Street SuiteSE DECISION MADE: 15-JUN-17
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alma Q
Alma Lasers LTD                   510(k) NO: K170850(Traditional)
ATTN: Rekha  Anand                PHONE NO : 972 4 2665663 
Halamish St Pob 3021 Industrial PaSE DECISION MADE: 15-JUN-17
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
Maine Standards Company LLC       510(k) NO: K170864(Traditional)
ATTN: James  Champlin             PHONE NO : 207 8921300 
221 US Route 1                    SE DECISION MADE: 21-JUN-17
Cumberland Foreside ME  04110     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus SLiK Fix Screw
Parcus Medical                    510(k) NO: K170877(Traditional)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 02-JUN-17
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound & Pr510(k) NO: K170878(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 14-JUN-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray NGDS Warrior Panel
BioFire Defense, LLC              510(k) NO: K170883(Traditional)
ATTN: Cynthia  Phillips           PHONE NO : 801 2623592 1370
79 West 4500 South, Suite 14      SE DECISION MADE: 22-JUN-17
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TELIX K Interbody System
Biedermann Motech GmbH & Co. KG   510(k) NO: K170890(Traditional)
ATTN: Gerd  Federle               PHONE NO : 49 7720 8510545 
Bertha-von-Suttner-Straße 23      SE DECISION MADE: 02-JUN-17
Villingen-Schwenningen  DE 78054  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise Glenoid Positioning System
Materialise NV                    510(k) NO: K170893(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 163 96280 
Technologielaan 15                SE DECISION MADE: 19-JUN-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Admira Fusion x-base
VOCO GmbH                         510(k) NO: K170896(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 472 17190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 29-JUN-17
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
SPR Therapeutics, LLC             510(k) NO: K170902(Traditional)
ATTN: Kathryn  Stager             PHONE NO : 216 3789108 
22901 Millcreek Blvd., Suite 110  SE DECISION MADE: 26-JUN-17
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compex Wireless USA
DJO, LLC                          510(k) NO: K170903(Traditional)
ATTN: Natalia  Shirina            PHONE NO : 760 7343049 
1430 Decision Street              SE DECISION MADE: 19-JUN-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Horizon PET/CT
Siemens Medical Solutions USA, Inc510(k) NO: K170904(Special)
ATTN: Alaine  Medio               PHONE NO : 865 2182703 
810 Innovation Drive              SE DECISION MADE: 01-JUN-17
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinix INFX-8000V, V6.40
Toshiba Medical Systems Coroporati510(k) NO: K170909(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 16-JUN-17
Otawara-Shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Complex Sport Elite
DJO, LLC                          510(k) NO: K170918(Traditional)
ATTN: Natalia  Shirina            PHONE NO : 760 7343049 
1430 Decision Street              SE DECISION MADE: 20-JUN-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
Innovative Health, LLC.           510(k) NO: K170922(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5255972 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 22-JUN-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Hydrophilic Guide Wire
Merit Medical Systems, Inc.       510(k) NO: K170933(Special)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 22-JUN-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rickettsia Real-time PCR Assay
Centers for Disease Control and Pr510(k) NO: K170940(Traditional)
ATTN: Yon  Yu                     PHONE NO : 404 6394643 
1600 Clifton Road MS-C18          SE DECISION MADE: 29-JUN-17
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive CoRoent Small Interlock II System
NuVasive, Incorporated            510(k) NO: K170961(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 08-JUN-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® CoRoent® Thoracolumbar System
NuVasive, Incorporated            510(k) NO: K170962(Traditional)
ATTN: Marysa E. Loustalot         PHONE NO : 858 9093360 
7475 Lusk Blvd.                   SE DECISION MADE: 26-JUN-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TONOPORT VI
PAR Medizintechnik GmbH & Co. KG  510(k) NO: K170966(Special)
ATTN: Buelent  Tek                PHONE NO : 49 30 2350700 
Sachsendamm 6                     SE DECISION MADE: 14-JUN-17
Berlin  DE 10829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intraskan DC Plus
Skanray Technologies Private Limit510(k) NO: K170967(Special)
ATTN: Mahadevan  J.               PHONE NO : 91 821 2415559 
Plot 15-17, Hebbal Industrial AreaSE DECISION MADE: 08-JUN-17
Mysore  IN 570016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalWatch Software User Interface
VitalConnect, Inc.                510(k) NO: K170973(Traditional)
ATTN: Kevin  Potgieter            PHONE NO : 1 408 9634600 
224 Airport Parkway, Suite 300    SE DECISION MADE: 02-JUN-17
San Jose CA  95110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcuNav V 10F Ultrasound Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K170992(Traditional)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 15-JUN-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrocardiograph
Edan Instruments, Inc.            510(k) NO: K170995(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 02-JUN-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wingman 14C Crossing Catheter
ReFlow Medical, Inc.              510(k) NO: K170996(Special)
ATTN: Rebecca K. Pine             PHONE NO : 1 760 8095178 
1003 Calle Sombra                 SE DECISION MADE: 09-JUN-17
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LASEMD Laser System
Lutronic Corporation              510(k) NO: K171009(Traditional)
ATTN: Jhung Won Vojir             PHONE NO : 82 31 9083440 
219, Sowon-ro, Haengsin-dong      SE DECISION MADE: 23-JUN-17
Deogyang-gu, Goyang-si  KR 410-220510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution ACT
GE Hangwei Medical Systems, Co., L510(k) NO: K171013(Traditional)
ATTN: Wang  Xing                  PHONE NO : 86 10 57388271 
West Area of Building No.3, No.1 YSE DECISION MADE: 05-JUN-17
Beijing Economic and Technological510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Polyisoprene Powder Free Surgical Gloves
Better Care Plastic Technology Co.510(k) NO: K171047(Traditional)
ATTN: Zhu  Chunyan                PHONE NO : 86 311 83601854 
Fuqian Xi Road, West District of SSE DECISION MADE: 22-JUN-17
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Dynamics Version VA30
Siemens Healthcare GmbH           510(k) NO: K171053(Third Party - Traditional)
ATTN: Lauren  Bentley             PHONE NO : 1 610 4486104 
Henkestrasse 127                  SE DECISION MADE: 01-JUN-17
Erlangen  DE 91052                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OrthoButton AL
Riverpoint Medical                510(k) NO: K171060(Special)
ATTN: Nathan  Cook                PHONE NO : 503 5178001 
825 NE 25TH Avenue                SE DECISION MADE: 02-JUN-17
Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Covidien, llc                     510(k) NO: K171066(Traditional)
ATTN: Sharon  McDermott           PHONE NO : 303 5816789 
5920 Longbow Drive                SE DECISION MADE: 08-JUN-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accuray Precision Treatment Planning System
Accuray Incorporated              510(k) NO: K171086(Traditional)
ATTN: Shweta  Kaushik             PHONE NO : 408 7164600 
1310 Chesapeake Terrace           SE DECISION MADE: 08-JUN-17
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cochlear Baha SoundArc
Cochlear Americas                 510(k) NO: K171088(Special)
ATTN: Beth  Murray                PHONE NO : 303 7909010 
13059 E. Peakview Avenue          SE DECISION MADE: 07-JUN-17
Centennial CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Closed Male Luer
Yukon Medical                     510(k) NO: K171101(Third Party - Traditional)
ATTN: Todd  Korogi                PHONE NO : 919 5958250 
4021 Stirrup Creek Dr. Suite #200 SE DECISION MADE: 02-JUN-17
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sculpsure
Cynosure, Inc                     510(k) NO: K171111(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Caelisle Road                   SE DECISION MADE: 13-JUN-17
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trifore(tm) Cervical Plating System
NeuroStructures, Inc.             510(k) NO: K171112(Traditional)
ATTN: Kathleen  Wong              PHONE NO : 949 3704497 
16 Technology Drive, Suite 165    SE DECISION MADE: 08-JUN-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
Arrow International, Inc.  (Subsid510(k) NO: K171146(Special)
ATTN: Fallon  Young               PHONE NO : 610 9847188 
2400 Bernville Road               SE DECISION MADE: 23-JUN-17
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PolyDev Soft Contact Lenses
Polydev Ltd.                      510(k) NO: K171157(Traditional)
ATTN: John  Mulvihill             PHONE NO : 353 87 6873128 
Tinure Rd                         SE DECISION MADE: 02-JUN-17
Collon  IE                        510(k) STATEMENT
                                                    

DEVICE: Contact Lens Case Round Glasses
FiftyTwoWays Ltd                  510(k) NO: K171163(Traditional)
ATTN: Jos  Reinders               PHONE NO : 852 94378276 
Unit 4, 7th Floor, Flat B, Grand ISE DECISION MADE: 27-JUN-17
Kwai Chung  HK                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ossler Exam Scope
LR Med Inc                        510(k) NO: K171188(Traditional)
ATTN: Prashant  Deshpande         PHONE NO : 708 9030100 
1450, Tomlin Drive Burr Ridge     SE DECISION MADE: 23-JUN-17
Burr Ridge IL  60527              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Toshiba Package; VSTP-001A
Toshiba Medical Systems Corporatio510(k) NO: K171222(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 08-JUN-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum TTC Biliary Balloon Dilator
Wilson-Cook Medical, Inc          510(k) NO: K171223(Traditional)
ATTN: Tiffanny A. Thomas          PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 16-JUN-17
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoform Topical Matrix
Aroa Biosurgery                   510(k) NO: K171231(Traditional)
ATTN: Tina  O’Brien               PHONE NO : 64 09 8693035 
2 Kingsford Smith Place           SE DECISION MADE: 14-JUN-17
Airport Oaks  NZ 2022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TULA Tube Delivery System
Tusker Medical                    510(k) NO: K171239(Special)
ATTN: Pavan  Sethi                PHONE NO : 408 5137529 
155 Jefferson Drive Suite 200     SE DECISION MADE: 28-JUN-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quingo Flyte Mobility Scooter
Agile Distributors LLC            510(k) NO: K171256(Traditional)
ATTN: Steven  Mahaffy             PHONE NO : 480 6597180 
2283 East Zion Way                SE DECISION MADE: 08-JUN-17
Chandler AZ  85249                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT BG Matrix Bone Graft Substitute
Prosidyan, Inc                    510(k) NO: K171284(Traditional)
ATTN: Charanpreet S. Bagga        PHONE NO : 908 5173666 
30 Technology Drive               SE DECISION MADE: 30-JUN-17
Warren NJ  07059                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
EndoGastric Solutions, Inc.       510(k) NO: K171307(Traditional)
ATTN: Steve  Hoffman              PHONE NO : 425 3079226 
18109 NE 76th Street Suite 100    SE DECISION MADE: 22-JUN-17
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tubing Pack
Medtronic, Inc.                   510(k) NO: K171308(Special)
ATTN: Renee  Cveykus              PHONE NO : 763 5053059 
8200  Coral Sea Street NE (MVS83) SE DECISION MADE: 02-JUN-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
Surgical Instrument Service and Sa510(k) NO: K171324(Traditional)
ATTN: Brandi J. Panteleon         PHONE NO : 541 9233310 
(dba) Medline ReNewal) 1500 NE HemSE DECISION MADE: 23-JUN-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venture 038 catheter
Vascular Solutions, Inc.          510(k) NO: K171335(Special)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court N             SE DECISION MADE: 07-JUN-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenocor Xenoscope Laparoscopic System
Xenocor, Inc                      510(k) NO: K171344(Special)
ATTN: Spencer  Walker             PHONE NO : 801 5815080 
630 Komas Dr. Suite 200           SE DECISION MADE: 01-JUN-17
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Xeridiem Medical Devices          510(k) NO: K171347(Special)
ATTN: Steve  Murray               PHONE NO : 520 88277694 
4700 S. Overland Dr.              SE DECISION MADE: 06-JUN-17
Tucson AZ  85714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
MinXray, Inc.                     510(k) NO: K171353(Special)
ATTN: Keith  Kretchmer            PHONE NO : 847 5640323 
3611 Commercial Ave               SE DECISION MADE: 07-JUN-17
Northbrook IL  60062              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiMend PRS Meshed, Revize-X
Integra LifeSciences Corporation (510(k) NO: K171357(Special)
ATTN: Kavita  Amin                PHONE NO : 617 2681616 
7 Elkins Street                   SE DECISION MADE: 07-JUN-17
Boston MA  02127                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1417WGC_127um and 1417WGC_140um
Rayence Co., Ltd                  510(k) NO: K171417(Special)
ATTN: Kevin  Kim                  PHONE NO : 82 318 0156459 
14, Samsung 1-ro, 1-gil           SE DECISION MADE: 12-JUN-17
Hwaseong-si  KP 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1417WCC_127um and1417WCC_140um
Rayence Co., Ltd                  510(k) NO: K171418(Special)
ATTN: Kevin  Kim                  PHONE NO : 82 318 0156459 
14, Samsung 1-ro, 1-gil           SE DECISION MADE: 12-JUN-17
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1717SGC_127um and 1717SGC_140um
Rayence Co., Ltd                  510(k) NO: K171419(Special)
ATTN: Kevin  Kim                  PHONE NO : 82 318 0156459 
14, Samsung 1-ro, 1-gil           SE DECISION MADE: 09-JUN-17
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1717SCC_127um and 1717SCC_140um
Rayence Co., Ltd                  510(k) NO: K171420(Special)
ATTN: Kevin  Kim                  PHONE NO : 82 318 0156459 
14, Samsung 1-ro, 1-gil           SE DECISION MADE: 09-JUN-17
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
Intuitive Surgical, Inc.          510(k) NO: K171426(Special)
ATTN: Brittany  Cunningham        PHONE NO : 408 5230602 
1266 Kifer Road                   SE DECISION MADE: 13-JUN-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
Medtronic Vascular, Inc.          510(k) NO: K171427(Special)
ATTN: Burt  Goodson               PHONE NO : 408 5857310 
3850 Brickway Blvd                SE DECISION MADE: 13-JUN-17
Santa Rosa CA  95403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnetic Surgical System
Levita Magnetics International Cor510(k) NO: K171429(Special)
ATTN: Alberto  Rodrigues-Navarro  PHONE NO : 650 2410320 
1730 S. Amphlett Blvd, Suite 240  SE DECISION MADE: 06-JUN-17
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoSite X-Porte Ultrasound System
FujiFilm SonoSite, Inc.           510(k) NO: K171437(Third Party - Traditional)
ATTN: Jordan Lydia Grimmer        PHONE NO : 425 9516984 
21919 30th Drive SE               SE DECISION MADE: 12-JUN-17
Bothell WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Palisade™ Pedicular Fixation System
Spineology Inc.                   510(k) NO: K171438(Special)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 02-JUN-17
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUSE Spinal System
Medtronic Sofamor Danek           510(k) NO: K171468(Special)
ATTN: Ankit K. Shah               PHONE NO : 901 3441272 
1800 Pyramid Pl.                  SE DECISION MADE: 13-JUN-17
Memphis TN  38125                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagVita TMS Therapy System
Tonica Elektronik A/S             510(k) NO: K171481(Special)
ATTN: Lise  Terkelsen             PHONE NO : 45 44 998444 
Lucernemarken 15                  SE DECISION MADE: 16-JUN-17
Farum  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hema-screen SPECIFIC Gold
Immunostics, Inc.                 510(k) NO: K171484(Special)
ATTN: Elizabeth  Galella          PHONE NO : 732 9180770 
1750 Brielle Ave. Suite A5        SE DECISION MADE: 14-JUN-17
Ocean NJ  07712                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BSD4343R Digital Flat Panel X-ray Detector
Bontech Inc.                      510(k) NO: K171485(Special)
ATTN: Kwang S. Choi               PHONE NO : 82 313 035254 
Youngtong-gu Youngtong-dong 980-3 SE DECISION MADE: 21-JUN-17
Suwon-si  KR 443-702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TroClose1200, TroClose1200 Cannula
Gordian Surgical Ltd.             510(k) NO: K171494(Special)
ATTN: Amir  Schvartzer            PHONE NO : 972 72 2607016 
17 Tchelet Street                 SE DECISION MADE: 15-JUN-17
Misgav Business Park  IL 2017400  510(k) STATEMENT
                                                    

DEVICE: Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
Medyssey USA, Inc.                510(k) NO: K171509(Special)
ATTN: Shawn  Kim                  PHONE NO : 
1550 East Higgins Road, Suite 123 SE DECISION MADE: 12-JUN-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
BIOTRONIK, Inc.                   510(k) NO: K171514(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 29-JUN-17
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
Ahlstrom Nonwovens LLC            510(k) NO: K171533(Traditional)
ATTN: Gary  Jackson               PHONE NO : 860 6548556 
2 Elm Street                      SE DECISION MADE: 29-JUN-17
Windsor Locks CT  06096           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation
RaySearch Laboratories AB (publ)  510(k) NO: K171536(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 722 366110 
Sveav 44                          SE DECISION MADE: 27-JUN-17
Stockholm  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cure™ Lumbar Plate System
Meditech Spine, LLC               510(k) NO: K171538(Traditional)
ATTN: Bruce  Dunaway              PHONE NO : 678 9745287 
1447 Peachtree St NE Suite 440    SE DECISION MADE: 16-JUN-17
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart External Drain (SED) System
Aqueduct Critical Care, Inc       510(k) NO: K171586(Special)
ATTN: Thomas  Clement             PHONE NO : 425 9851571 
11822 North Creek Parkway North, SSE DECISION MADE: 30-JUN-17
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Distal Elbow Plating System
Skeletal Dynamics, LLC            510(k) NO: K171590(Special)
ATTN: Ana M. Escagedo             PHONE NO : 305 5967585 
8905 SW 87 Avenue, Suite 201      SE DECISION MADE: 27-JUN-17
Miami FL  33176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
Mcube Technology Co., Ltd.        510(k) NO: K171591(Third Party - Traditional)
ATTN: Changhyun  Kim              PHONE NO : 82 023 4217780 
#803, 123, Bonghwasan-ro Jungnang-SE DECISION MADE: 22-JUN-17
Seoul  KR 02048                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: AOS Anterolateral Proximal Humeral Plate
Advanced Orthopaedic Solutions, In510(k) NO: K171606(Special)
ATTN: Alex  Bhaskarla             PHONE NO : 310 5339966 
3203 Kashiwa Street               SE DECISION MADE: 22-JUN-17
Torrance CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUITY Pro Lead Delivery System
Boston Scientific Corporation     510(k) NO: K171612(Special)
ATTN: Lori  Berends               PHONE NO : 763 4941528 
Three Scimed Place                SE DECISION MADE: 30-JUN-17
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
Welch Allyn, Inc.                 510(k) NO: K171621(Special)
ATTN: Mark  Alsberge              PHONE NO : 315 6854471 
4341 State Street Road            SE DECISION MADE: 30-JUN-17
Skaneateles Falls NY  13153       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity-Lock 3, Infinity-Lock 5
Xiros Ltd                         510(k) NO: K171680(Special)
ATTN: Stephen  Seed               PHONE NO : 44 011 32387200 
Springfield House, Whitehouse LaneSE DECISION MADE: 30-JUN-17
Leeds  GB LS197UE                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew 25 Fluid Management System
Smith & Nephew, Inc.              510(k) NO: K171794(Special)
ATTN: Kathleen  Solomon           PHONE NO : 978 7491605 
150 Minuteman Road                SE DECISION MADE: 27-JUN-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    


       TOTAL 510(k)s THIS PERIOD   288                                     
       TOTAL WITH SUMMARIES        277                                     
       TOTAL WITH STATEMENTS        11
                                      

Page Last Updated: 12/06/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English