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  1. 510(k) Clearances

March 2017 510(k) Clearances

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


DEVICE: Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
TIANJIN EMPECS MEDICAL DEVICE CO.,510(k) NO: K152534(Special)
ATTN: CHAE CHUNG LYUEL            PHONE NO : 82 70 71240474 
NO.35 AND 37, YINGCHENG STREET    SE DECISION MADE: 21-MAR-17
HANGU  CN 300480                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dextramer CMV Kit
Immudex Aps                       510(k) NO: K153538(Traditional)
ATTN: Liselotte   Brix            PHONE NO : 45 4 0910121 
Fruebjergvej 3                    SE DECISION MADE: 02-MAR-17
Copenhagen  DK 2100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Consult Station TS
H4D SAS                           510(k) NO: K153600(Traditional)
ATTN: MARTA  RIVAS                PHONE NO : 33 170 814949 
92 AVENUE KLEBER                  SE DECISION MADE: 17-MAR-17
PARIS  FR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Edi Catheter ENFit
MAQUET CRITICAL CARE AB           510(k) NO: K153688(Traditional)
ATTN: MIRVA  BOOTHE               PHONE NO : 46 10 3357300 
RONTGENVAGEN 2                    SE DECISION MADE: 02-MAR-17
SOLNA  SE SE-171 54               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RenovoCath
RenovoRx, Inc.                    510(k) NO: K160067(Traditional)
ATTN: Kamran  Najmabadi           PHONE NO : 650 2844433 
4546 El Camino Real, Suite 282    SE DECISION MADE: 07-MAR-17
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luggie Chair
FREERIDER CORPORATION             510(k) NO: K160139(Traditional)
ATTN: Arthur  Wang                PHONE NO : 886 762 23093 
NO.22 BENGONG 5TH ROAD            SE DECISION MADE: 20-MAR-17
Kang-Shan Dist  TW 820            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid Barostat Bag (RBB) Pump and Catheter
MUI SCIENTIFIC                    510(k) NO: K160287(Traditional)
ATTN: TAMMY  MUI                  PHONE NO : 905 8905525 
145 TRADERS BLVD. EAST #33-34     SE DECISION MADE: 14-MAR-17
MISSISSAUGA  CA L4Z 3L3           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glass Ionomer Cement
SHANDONG HUGE DENTAL MATERIAL CORP510(k) NO: K160345(Traditional)
ATTN: Steven  Song                PHONE NO : 086 633 2277285 
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 03-MAR-17
Rizhao City  CN 276800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K3PRO Konus Additional Abutments and Implants
ARGON MED. PRODUCTIONS VERTRIEBS G510(k) NO: K160581(Traditional)
ATTN: RICHARD   DONACA            PHONE NO : 011 4967 2130960 
MAINZER STR 346                   SE DECISION MADE: 24-MAR-17
BINGEN AM RHEIN  DE 55411         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire Platinum Revascularization Device, 6x40 mm
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K160641(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 2975489 
9775 Toledo Way                   SE DECISION MADE: 08-MAR-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
MAQUET CRITICAL CARE AB           510(k) NO: K160665(Abbreviated)
ATTN: CARINA  LUNDBERG            PHONE NO : 011 461 03357300 
RONTGENVAGEN 2                    SE DECISION MADE: 29-MAR-17
SOLNA  SE SE-171 54               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vado Steerable Sheath
KALILA MEDICAL, INC.              510(k) NO: K160721(Traditional)
ATTN: Carrie  Neuberger           PHONE NO : 408 6372150 
745 CAMDEN AVE, SUITE A           SE DECISION MADE: 07-MAR-17
CAMPBELL CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interstitial Needles
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K160815(Traditional)
ATTN: PETER  J. CORONADO          PHONE NO : 650 4246320 
911 HANSEN WAY                    SE DECISION MADE: 10-MAR-17
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RnD TE and RnD SE
Apex Dental Materials, Inc        510(k) NO: K161077(Traditional)
ATTN: Scott  Lamerand             PHONE NO : 847 7191133 
330 Telser Road                   SE DECISION MADE: 17-MAR-17
Lake Zurich IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
PENTAFERTE ITALIA S.R.L.          510(k) NO: K161141(Traditional)
ATTN: ROSA  DI GIOIA              PHONE NO : 39 086 1560201 
LOC. NOCELLA SP 262               SE DECISION MADE: 22-MAR-17
CAMPLI  IT I-64012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OC-FLEX Flexible IntraOral Cannula
Venture Therapeutics, Inc.        510(k) NO: K161250(Traditional)
ATTN: Marilyn A. Friedly          PHONE NO : 614 4303300 
6525 Doubletree Avenue            SE DECISION MADE: 17-MAR-17
Columbus OH  43229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiPulse HoPLUS
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K161257(Special)
ATTN: ANTJE  KATZER               PHONE NO : 49 364 17700309 
BRUESSELER STR. 10                SE DECISION MADE: 31-MAR-17
JENA  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoPur Filter
Nephros Inc.                      510(k) NO: K161304(Traditional)
ATTN: Hollie  Johnson             PHONE NO : 1 201 3435202 
41 Grand Ave                      SE DECISION MADE: 02-MAR-17
River Edge NJ  07661              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
TEDAN SURGICAL INNOVATIONS LLC    510(k) NO: K161318(Traditional)
ATTN: John   Willis               PHONE NO : 713 7260886 
12615 W. AIRPORT BLVD, SUITE 200  SE DECISION MADE: 20-MAR-17
SUGAR LAND TX  77478              510(k) STATEMENT
                                                    

DEVICE: Multi-unit Abutment Plus
NOBEL BIOCARE AB                  510(k) NO: K161416(Traditional)
ATTN: Charlemagne   Chua          PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 16-MAR-17
GOTEBORG  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PerfectSmooth
SHEN ZHEN COSBEAUTY CO.,LTD.      510(k) NO: K161428(Traditional)
ATTN: Nicole   Hu                 PHONE NO : 86 755 86271293 8806
UNIT A- 3F, QIAO DE INDUSTRIAL PARSE DECISION MADE: 23-MAR-17
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Myoject Luer Lock Needle Electrode
Natus Manufacturing Limited       510(k) NO: K161430(Traditional)
ATTN: Michael  Galvin             PHONE NO : 353 091 630043 
IDA Business Park                 SE DECISION MADE: 02-MAR-17
Gort  IE                          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plum 360™ Infusion System with MedNet/ Smart Card Plug ‘n’ Play Module
Hospira, Inc                      510(k) NO: K161469(Traditional)
ATTN: Keith  Dunn                 PHONE NO : 224 2124898 
275 North Field Drive             SE DECISION MADE: 28-MAR-17
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bluetooth blood pressure monitor
SHENZHEN KINGYIELD TECHNOLOGY CO.,510(k) NO: K161530(Special)
ATTN: Dacheng   Gong              PHONE NO : 86 755 27371997 
BLDG C, FUHAI INDUSTRIAL ZONE, FUHSE DECISION MADE: 31-MAR-17
SHENZHEN  CN 518000               510(k) STATEMENT
                                                    

DEVICE: Transem and EchoGen Embryo Transfer Catheters
ORIGIO A/S                        510(k) NO: K161547(Traditional)
ATTN: TOVE  KJAER                 PHONE NO : 45 46 790202 
KNARDRUPVEJ 2                     SE DECISION MADE: 09-MAR-17
MAALOEV  DK 2760                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOFLATOR 40, ENDOFLATOR 50
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K161554(Traditional)
ATTN: SUSIE S. CHEN               PHONE NO : 424 2188201 
2151 E. GRAND AVENUE              SE DECISION MADE: 02-MAR-17
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelZygoma 0°
Nobel Biocare AB                  510(k) NO: K161598(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Box 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 14-MAR-17
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REXLON, REXSIL
SM ENG CO., LTD                   510(k) NO: K161633(Traditional)
ATTN: SOON-GU  LEE                PHONE NO : 82 51 3058016 
46, NAKDONG-DAERO 1302BEON-GIL    SE DECISION MADE: 02-MAR-17
SASANG-GU  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMIStem-H Proximal Coating
MEDACTA INTERNATIONAL SA          510(k) NO: K161635(Traditional)
ATTN: STEFANO  BAJ                PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 31-MAR-17
CASTEL SAN PIETRO  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire Infusion Pump
Q Core Medical Ltd.               510(k) NO: K161667(Traditional)
ATTN: Shimon  Vaknin              PHONE NO : 972 73 2388803 
29 Yad Haruzim St.                SE DECISION MADE: 27-MAR-17
Netanya  IL 4250529               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDICON Spinal Spreading Systems
MEDICON EG                        510(k) NO: K161680(Traditional)
ATTN: Joachim  Schmid             PHONE NO : 49 7462 20090 
GANSACKER 15                      SE DECISION MADE: 24-MAR-17
TUTTLINGEN  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nipro SafeTouch IV Catheter
NIPRO MEDICAL CORPORATION         510(k) NO: K161681(Traditional)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 5997174 
3150 NW 107TH AVE.                SE DECISION MADE: 08-MAR-17
MIAMI FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Direct LDL Cholesterol (LDL)
RANDOX LABORATORIES LIMITED       510(k) NO: K161691(Traditional)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 028 94422413 2275
55 DIAMOND ROAD CRUMLIN           SE DECISION MADE: 20-MAR-17
CRUMLIN  GB BT29 4QY              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U2 Total Knee System E-XPE products
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K161705(Traditional)
ATTN: KAREN  HO                   PHONE NO : 886 357 73351 2212
NO 57, PARK AVE 2 SCIENCE PARK    SE DECISION MADE: 16-MAR-17
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cleveland Multiport Ventricular Catheter Set
Parker Hannifin Corp.             510(k) NO: K161731(Traditional)
ATTN: George  Austria             PHONE NO : 805 6582984 
3007 Bunsen Ave.                  SE DECISION MADE: 27-MAR-17
Ventura CA  93003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Sorin Group Italia S.r.l          510(k) NO: K161733(Traditional)
ATTN: Luigi  Vecchi               PHONE NO : 011 39 053529811 
86, Via Statale 12 Nord           SE DECISION MADE: 08-MAR-17
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
MYCO MEDICAL                      510(k) NO: K161737(Abbreviated)
ATTN: Sanjiv  Kumar               PHONE NO : 919 4602535 
158 TOWERVIEW COURT               SE DECISION MADE: 02-MAR-17
CARY NC  27513                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THD ANOPRESS
THD SPA                           510(k) NO: K161785(Traditional)
ATTN: GIUSEPPINA  GIANNINI        PHONE NO : 39 0522 634311 
VIA DELL'INDUSTRIA 1              SE DECISION MADE: 14-MAR-17
CORREGGIO  IT 42015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freedom Syringe
Procedure Products, Inc.          510(k) NO: K161812(Abbreviated)
ATTN: Doug  Rowley                PHONE NO : 360 6931832 
1801 W. 4th Plain Blvd.           SE DECISION MADE: 27-MAR-17
Vancouver WA  98660               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
bioMerieux, Inc.                  510(k) NO: K161816(Traditional)
ATTN: Jolyn  Tenllado             PHONE NO : 314 7318386 
595 Anglum Rd.                    SE DECISION MADE: 28-MAR-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iovera system
Myoscience, Inc                   510(k) NO: K161835(Traditional)
ATTN: Tracey  Henry               PHONE NO : 510 9331500 
46400 Fremont blvd                SE DECISION MADE: 24-MAR-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
Waldemar Link GmbH & Co. KG       510(k) NO: K161840(Traditional)
ATTN: Lorenz  Runge               PHONE NO : 49 40 53995305 
Oststrabe 4-10                    SE DECISION MADE: 16-MAR-17
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSage Rx (iSage Rx Basal Insulin Titration)
iSag Rx, Inc.                     510(k) NO: K161865(Traditional)
ATTN: RYAN  SYSKO                 PHONE NO : 302 9830001 
206 ALAPOCAS DR                   SE DECISION MADE: 07-MAR-17
WILMINGTON DE  19803              510(k) STATEMENT
                                                    

DEVICE: NIVR58-T kit
Barco N.V.                        510(k) NO: K161880(Special)
ATTN: Lieven De Wandel            PHONE NO : 32 56 233459 
President Kennedypark 35          SE DECISION MADE: 14-MAR-17
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Slimming Treatment Device
BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K161892(Traditional)
ATTN: Li  Yanzhe                  PHONE NO : 86 10 56370050 607
72 bldg., Golden bridge S&T indus.SE DECISION MADE: 02-MAR-17
Beijing  CN 101102                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
BEIJING FERT TECHNOLOGY CO., LTD  510(k) NO: K161898(Traditional)
ATTN: MENG  ZHANG                 PHONE NO : 86 108 3849578 
NO.9, ZHANGGUOZHUANG VILLAGE, CHANSE DECISION MADE: 08-MAR-17
Beijing  CN 100072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SREE MRI Transport Incubator
ADVANCED IMAGING RESEARCH DBA SREE510(k) NO: K161918(Traditional)
ATTN: RAVI  SRINIVASAN            PHONE NO : 216 4261461 
PO BOX 603220                     SE DECISION MADE: 03-MAR-17
CLEVELAND OH  44103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
Dipped Products (Thailand) Limited510(k) NO: K161929(Traditional)
ATTN: Nilaksha  Pushpakumara      PHONE NO : 00 66 74302100 
82/2 MOO 9, Tumbon Rattapum       SE DECISION MADE: 29-MAR-17
Amphur Khun  Nieng  TH 90220      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics    510(k) NO: K161954(Traditional)
ATTN: Justin  DiValentino         PHONE NO : 914 5242280 
511 Benedict Avenue               SE DECISION MADE: 09-MAR-17
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENFit enteral syringe
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K161979(Traditional)
ATTN: JUN  LU                     PHONE NO : 86 510 86205183 
NO.2, TAIFU ROAD, HUASHI TOWN     SE DECISION MADE: 22-MAR-17
JIANGYIN  CN 214421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curasite
IZUN PHARMACEUTICALS              510(k) NO: K161991(Traditional)
ATTN: JACK  TALLEY                PHONE NO : 858 3351300 
ONE ROCKEFELLER PLAZA, 11TH FLOOR SE DECISION MADE: 03-MAR-17
NEW YORK NY  10020                510(k) STATEMENT
                                                    

DEVICE: CardioDay V2.5
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K162023(Traditional)
ATTN: BERT  SCHADOW               PHONE NO : 49 332 8394270 
ODERSTR. 77                       SE DECISION MADE: 24-MAR-17
TELTOW  DE 14513                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
MicroPort Orthopedics, Inc.       510(k) NO: K162026(Traditional)
ATTN: Byron  Ledbetter            PHONE NO : 901 2905943 
5677 Airline Road                 SE DECISION MADE: 01-MAR-17
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREMIUM - SHELTA Prosthetic Components
SWEDEN & MARTINA S.p.A.           510(k) NO: K162028(Traditional)
ATTN: ALESSIA  PEZZATO            PHONE NO : 39 049 9124300 
via veneto, 10                    SE DECISION MADE: 24-MAR-17
Due Carrare  IT 35020             510(k) STATEMENT
                                                    

DEVICE: SALVATION External Fixation System
WRIGHT MEDICAL                    510(k) NO: K162033(Traditional)
ATTN: LESLIE  FITCH               PHONE NO : 901 8674120 
1023 CHERRY ROAD                  SE DECISION MADE: 06-MAR-17
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK Sphere
Medacta International SA          510(k) NO: K162035(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 06-MAR-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse with VEMP
INTERACOUSTICS A/S                510(k) NO: K162037(Traditional)
ATTN: Erik  Nielsen               PHONE NO : 45 637 13555 
AUDIOMETER ALLE 1                 SE DECISION MADE: 23-MAR-17
Middelfart  DK 5500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentca Denture Base II
DENTCA, Inc.                      510(k) NO: K162044(Traditional)
ATTN: Jason  Lee                  PHONE NO : 424 5588726 
357 Van Ness Way #250             SE DECISION MADE: 03-MAR-17
Torrance CA  90501                510(k) STATEMENT
                                                    

DEVICE: JOINIX CANNULAR SYSTEM
AJU Pharm Co.,Ltd.                510(k) NO: K162070(Traditional)
ATTN: Kim Jung Gil                PHONE NO : 82 31 7654420 
A-207, 697, Pangyo-ro             SE DECISION MADE: 16-MAR-17
Seongnam-si  KR 13511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
DePuy Synthes                     510(k) NO: K162124(Traditional)
ATTN: CHRISTOPHER J. MEDBERRY     PHONE NO : 610 7196806 
1301 GOSHEN PARKWAY               SE DECISION MADE: 29-MAR-17
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caphosol Artifical Saliva Tablets
EUSA Pharma (UK) Limited          510(k) NO: K162167(Traditional)
ATTN: Paul  Davisson              PHONE NO : 44 1732 832317 
Breakspear Park, Breakspear Way   SE DECISION MADE: 31-MAR-17
Hemel Hempstead  GB HP2-4TZ       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
BRIGHTWAY HOLDINGS SDN BHD        510(k) NO: K162186(Traditional)
ATTN: G.  BASKARAN                PHONE NO : 603  33431007 
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 31-MAR-17
KLANG  MY 42100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cascade IOMAX Intraoperative Monitor
CADWELL INDUSTRIES, INC.          510(k) NO: K162199(Traditional)
ATTN: MELISSA  KIRKUP             PHONE NO : 509 7356481 
909 NORTH KELLOGG STREET          SE DECISION MADE: 02-MAR-17
KENNEWICK WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOYON
Oculus Innovative Sciences        510(k) NO: K162217(Traditional)
ATTN: Brian W. Martin             PHONE NO : 707 2830550 
1129 N. McDowell Boulevard        SE DECISION MADE: 23-MAR-17
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUVENA VAGINAL MOISTURIZER & LUBRICANT
LACLEDE, INC.                     510(k) NO: K162235(Traditional)
ATTN: MICHAEL  PELLICO            PHONE NO : 310 6054280 
2103 E. UNIVERSITY DR.            SE DECISION MADE: 24-MAR-17
RANCHO DOMINGUEZ CA  90220        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOCI Total Vitamin D Total Assay, LOCI VITD CAL
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K162298(Traditional)
ATTN: KATHLEEN  DRAY-LYONS        PHONE NO : 781 8264551 
500 GBC DRIVE P.O. BOX 6101       SE DECISION MADE: 16-MAR-17
NEWARK DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noris Medical MBI-2mm Dental Implant System
Noris Medical Ltd                 510(k) NO: K162308(Traditional)
ATTN: Simha  Sibony               PHONE NO : 972 73 7964477 
8 Hataasia                        SE DECISION MADE: 17-MAR-17
Nesher  IL 3688808                510(k) STATEMENT
                                                    

DEVICE: StealthStation S8 System Platforms and StealthStation Cranial Software
MEDTRONIC NAVIGATION, INC.        510(k) NO: K162309(Traditional)
ATTN: Tia  Fushimi-Bain           PHONE NO : 720 8903200 
826 COAL CREEK CIRCLE             SE DECISION MADE: 31-MAR-17
LOUISVILLE CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann PrefGel
INSTITUT STRAUMANN AG             510(k) NO: K162311(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 41 61 9651260 
PETER MERIAN WEG 12               SE DECISION MADE: 07-MAR-17
BASEL  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Next Generation NVM5 System
NUVASIVE INCORPORATED             510(k) NO: K162313(Traditional)
ATTN: MARY  ADAMS                 PHONE NO : 909 9915235 
7475 LUSK BLVD.                   SE DECISION MADE: 16-MAR-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
Exactech Inc                      510(k) NO: K162325(Special)
ATTN: Zach  Sharrah               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 06-MAR-17
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stellaris Elite Vision Enhancement System
Bausch + Lomb                     510(k) NO: K162342(Traditional)
ATTN: Ken  Nehmer                 PHONE NO : 636 2263017 
3365 Tree Ct. Industrial Blvd.    SE DECISION MADE: 24-MAR-17
St. Louis MO  63122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesair Cystoscopic Sheath
Solace Therapeutics               510(k) NO: K162356(Special)
ATTN: William  Gruber             PHONE NO : 508 2831200 
135 Newbury St                    SE DECISION MADE: 02-MAR-17
Framingham MA  01701              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intellijoint HIP Generation 2A System
INTELLIJOINT SURGICAL INC.        510(k) NO: K162364(Traditional)
ATTN: BRANDON  GINGRICH           PHONE NO : 1 519 3423178 
60 BATHURST DR., UNIT 6           SE DECISION MADE: 02-MAR-17
WATERLOO  CA N2V 2A9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell Sierra Summit, Cadwell Sierra Ascent
CADWELL INDUSTRIES, INC.          510(k) NO: K162383(Traditional)
ATTN: CHRISTOPHER  BOLKAN         PHONE NO : 509 7356481 
909 NORTH KELLOGG STREET          SE DECISION MADE: 01-MAR-17
KENNEWICK WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRC-77tHR
Capintec, Inc.                    510(k) NO: K162394(Traditional)
ATTN: Mary Anne Yusko             PHONE NO : 201 8259500 
7 Vreeland Road                   SE DECISION MADE: 08-MAR-17
Florham Park NJ  07932            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K162405(Traditional)
ATTN: CHAN YEW MEN                PHONE NO : 605 8472777 
LOT 821, JALAN MATANG             SE DECISION MADE: 28-MAR-17
MATANG  MY 84750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TIPCAM 1S 3D System
KARL STORZ Endoscopy America, Inc 510(k) NO: K162410(Traditional)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E.Grand Avenue               SE DECISION MADE: 02-MAR-17
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoggan Scientific® microFET2™
Hoggan Scientific, LLC            510(k) NO: K162412(Traditional)
ATTN: Spencer  Walker             PHONE NO : 801 5815080 
3653 West 1987 South Bld. # 7     SE DECISION MADE: 09-MAR-17
Salt Lake City UT  84104          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
STERIS Corporation                510(k) NO: K162413(Traditional)
ATTN: Bill  Brodbeck              PHONE NO : 440 3542600 
5960 Heisley Rd                   SE DECISION MADE: 31-MAR-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra 9Plus
Uzinmedicare Company              510(k) NO: K162415(Traditional)
ATTN: Nathan  Ahn                 PHONE NO : 82 31 7395271 
Room 105, Joongang Induspia V, SagSE DECISION MADE: 15-MAR-17
Seoul  KR 13202                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZipE Knotless Tissue Repair and Attachment Devices
ZIPTEK, LLC                       510(k) NO: K162429(Traditional)
ATTN: William F. Bennett          PHONE NO : 941 9535509 
1250 S TAMIAMI TRL STE 303        SE DECISION MADE: 13-MAR-17
Sarasota FL  34239-2221           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hach CM130 Chlorine Monitoring System
HACH COMPANY                      510(k) NO: K162471(Traditional)
ATTN: Jeff  Ryberg                PHONE NO : 714 5167659 
100 DAYTON AVENUE                 SE DECISION MADE: 30-MAR-17
AMES IA  50010                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
Cardiac Insight, Inc.             510(k) NO: K162503(Traditional)
ATTN: Brad  Harlow                PHONE NO : 206 5962061 
3230 Carillon Point               SE DECISION MADE: 24-MAR-17
Kirkland WA  98033                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhotoFix Decellularized Bovine Pericardium
CryoLife, Inc.                    510(k) NO: K162506(Traditional)
ATTN: Heather  Emerick            PHONE NO : 770 4193355 4502
1655 Roberts Blvd., N.W.          SE DECISION MADE: 09-MAR-17
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Non-contact Thermometer, Model ACT8100
EASYWELL BIOMEDICALS, INC.        510(k) NO: K162509(Traditional)
ATTN: Arthur  Chen                PHONE NO : 886 36669596 
SUITE 2, 2F, NO.9, JHANYE 1ST RD, SE DECISION MADE: 10-MAR-17
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraCath Continuous Nerve block Catheter
TELEFLEX MEDICAL , INC.           510(k) NO: K162522(Traditional)
ATTN: James A. Cochie             PHONE NO : 919 4332703 
3015 Carrington Mill Blvd         SE DECISION MADE: 17-MAR-17
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AZUR CX Detachable 18 Peripheral Coil System
MicroVention, Inc                 510(k) NO: K162524(Traditional)
ATTN: Laraine  Pangelina          PHONE NO : 714 2478150 
1311 Valencia Avenue              SE DECISION MADE: 03-MAR-17
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigiX FDX
Allengers Medical Systems Limited 510(k) NO: K162529(Traditional)
ATTN: Manmohan  Singh             PHONE NO : 91 01762 662626 
Bhankharpur, Mubarakpur Road      SE DECISION MADE: 03-MAR-17
Derabassi, Distt Mohali  IN 140507510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multichem IA Plus
TECHNO-PATH MANUFACTURING         510(k) NO: K162530(Abbreviated)
ATTN: BERND  HASS                 PHONE NO : 353 61 525700 
BALLINA                           SE DECISION MADE: 31-MAR-17
CO. TIPPERARY  IE                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIGHTFUSION LED SYSTEM
VITAGE LED LTD                    510(k) NO: K162556(Traditional)
ATTN: SUE  D'ARCY                 PHONE NO : 44 0 3330142434 
THE PAVILLION, JOSSELIN ROAD      SE DECISION MADE: 24-MAR-17
BASILDON  GB SS131QB              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Move Forward 3D Motion Simulation Service
BIOMET  INC.                      510(k) NO: K162559(Traditional)
ATTN: PAUL  HARDY                 PHONE NO : 574 3726799 
56 EAST BELL DRIVE                SE DECISION MADE: 31-MAR-17
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
BCG MEDICAL, LLC                  510(k) NO: K162562(Traditional)
ATTN: LISA  GIAP                  PHONE NO : 858 3491331 
6715 RANCHO TOYON PLACE           SE DECISION MADE: 17-MAR-17
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-LINKPC System
ZAVATION, LLC                     510(k) NO: K162575(Traditional)
ATTN: FRANKIE  CUMMINS            PHONE NO : 601 9191119 
220 LAKELAND PARKWAY              SE DECISION MADE: 03-MAR-17
FLOWOOD MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardian Angel GA1000 Digital Vital Sign Monitoring System
TAIWAN AULISA MEDICAL DEVICES TECH510(k) NO: K162580(Traditional)
ATTN: ALAN  TANG                  PHONE NO : 886 2 26557297 18
RM. 1052, BLDG.H, 10F., NO.3-2, YUSE DECISION MADE: 03-MAR-17
TAIPEI CITY  TW 115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adscope 658 Electronic Stethoscope
AMERICAN DIAGNOSTIC CORP.         510(k) NO: K162589(Traditional)
ATTN: Michael  Falco              PHONE NO : 631 2739600 
55 COMMERCE DR.                   SE DECISION MADE: 10-MAR-17
HAUPPAUGE NY  11788               510(k) STATEMENT
                                                    

DEVICE: Mould Applicator Set
Varian Medical Systems, Inc       510(k) NO: K162615(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246230 
911 Hansen Way                    SE DECISION MADE: 24-MAR-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
TOP QUALITY GLOVE SDN. BHD        510(k) NO: K162626(Traditional)
ATTN: HUE KON FAH                 PHONE NO : 603 33923375 
LOT 4961, JALAN TERATAI, BATU 6, OSE DECISION MADE: 31-MAR-17
KLANG  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: EnsoSleep
EnsoData, Inc.                    510(k) NO: K162627(Traditional)
ATTN: Chris  Fernandez            PHONE NO : 630 8625738 
111 N. Fairchild Street, Suite 240SE DECISION MADE: 31-MAR-17
Madison WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
HARTALEGA NGC SDN. BHD.           510(k) NO: K162646(Traditional)
ATTN: KUAN MUN LEONG              PHONE NO : 603 62771733 
KAWASAN PERINDUSTRIAN TANJUNG,    SE DECISION MADE: 03-MAR-17
SEPANG  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: mollosil plus
DETAX GmbH & Co.KG                510(k) NO: K162654(Traditional)
ATTN: Antje  Reeps                PHONE NO : 49 7243 5100 
Carl-Zeiss-Str. 4                 SE DECISION MADE: 13-MAR-17
Ettlingen  DE 76275               510(k) STATEMENT
                                                    

DEVICE: VertebraLINK Fusion Platform
FACETLINK DBA LINKSPINE           510(k) NO: K162693(Traditional)
ATTN: MASSIMO  CALAFIORE          PHONE NO : 973 6274171 
101 ROUNDHILL DRIVE               SE DECISION MADE: 29-MAR-17
ROCKAWAY NJ  07866                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Assert Self-Contained Biological Indicator
STERIS CORPORATION                510(k) NO: K162701(Traditional)
ATTN: ANTHONY  PIOTRKOWSKI        PHONE NO : 440 3927437 
5960 HEISLEY RD                   SE DECISION MADE: 24-MAR-17
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse Implant System® - iFuse-3D implant
SI-BONE, INC.                     510(k) NO: K162733(Traditional)
ATTN: ROXANNE  DUBOIS             PHONE NO : 408 2070700 2236
3055 OLIN AVE, SUITE 2200         SE DECISION MADE: 10-MAR-17
SAN JOSE CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
BECKMAN COULTER, INC.             510(k) NO: K162740(Traditional)
ATTN: SHANNON  POPSON             PHONE NO : 916 3743330 
1584 ENTERPRISE BLVD              SE DECISION MADE: 21-MAR-17
WEST SACRAMENTO CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ontex and other proprietary names
ONTEX BVBA                        510(k) NO: K162746(Traditional)
ATTN: Henri  Lesage               PHONE NO : 32 52 454611 
5 Genthof                         SE DECISION MADE: 03-MAR-17
Buggenhout Oost-Vlaanderen  BE 925510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
STERIS Corporation                510(k) NO: K162758(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3542600 
5960 Heisley Rd                   SE DECISION MADE: 21-MAR-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silk'n HST
Home Skinovations Ltd.            510(k) NO: K162784(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 25-MAR-17
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foresight Intracardiac Echocardiology (ICE) System
Conavi Medical Inc.               510(k) NO: K162789(Traditional)
ATTN: Sam  Mostafavi              PHONE NO : 416 4830100 
293 Lesmill Road                  SE DECISION MADE: 28-MAR-17
Toronto  CA M3B 2V1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RHYTHMIA HDx Mapping System
Boston Scientific Corporation     510(k) NO: K162793(Traditional)
ATTN: Regina  Holmes              PHONE NO : 617 2183873 
125 Cambridgepark Drive Suite 600 SE DECISION MADE: 10-MAR-17
Cambridge MA  01752               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q2 Low Pressure Power Injection Extension Set
QUEST MEDICAL, INC.               510(k) NO: K162804(Traditional)
ATTN: Amy  Clendening-Wheeler     PHONE NO : 972 3326338 
ONE ALLENTOWN PARKWAY             SE DECISION MADE: 08-MAR-17
ALLEN TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Conditional CGA 870
Essex Industries, Inc.            510(k) NO: K162811(Traditional)
ATTN: Russ  Jacobsmeyer           PHONE NO : 314 3388723 
7700 Gravois                      SE DECISION MADE: 02-MAR-17
St. Louis MO  63123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AC3 Series IABP System
ARROW INTERNATIONAL, INC.         510(k) NO: K162820(Traditional)
ATTN: Alifiya  Jagmag             PHONE NO : 978 2505100 
16 ELIZABETH DR                   SE DECISION MADE: 31-MAR-17
Chelmsford MA  01824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Surgical System
FUJIFILM New Development U.S.A., I510(k) NO: K162836(Traditional)
ATTN: Stephen  Mariano            PHONE NO : 781 8602463 
318 Bear Hill Road                SE DECISION MADE: 13-MAR-17
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GuideMia Ortho+
GUIDEMIA TECHNOLOGIES, LLC        510(k) NO: K162850(Traditional)
ATTN: FEI  GAO                    PHONE NO : 714 3912739 
5030 KATELLA AVE., STE 209        SE DECISION MADE: 24-MAR-17
LOS ALAMITOS CA  90720            510(k) STATEMENT
                                                    

DEVICE: Exam Vue PACS
JPI Healthcare Solutions, Inc     510(k) NO: K162868(Traditional)
ATTN: Jang Won Lee                PHONE NO : 82 31 4913453 100
Woolim E-Biz Center #608, 170-5   SE DECISION MADE: 17-MAR-17
Kuro 3-Dong, Kuro_GU  KR 152-769  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIMLRE F1 and CIMILRE S3
CIMILRE CO., LTD.                 510(k) NO: K162870(Traditional)
ATTN: Ko Bong Jae                 PHONE NO : 82 31 7230941 
#201, 202, Sagimakgol-ro 148, JungSE DECISION MADE: 07-MAR-17
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEP Monitor
TONICA ELEKTRONIK A/S             510(k) NO: K162873(Traditional)
ATTN: LISE  TERKELSEN             PHONE NO : 45 4 4998444 
LUCERNEMARKEN 15                  SE DECISION MADE: 31-MAR-17
Farum  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TIPCAM 1S 3D System
KARL STORZ Endoscopy America, Inc 510(k) NO: K162880(Traditional)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E. Grand Avenue              SE DECISION MADE: 16-MAR-17
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
STRAUMANN USA, LLC                510(k) NO: K162890(Traditional)
ATTN: JENNIFER M. JACKSON         PHONE NO : 978 7472509 
60 MINUTEMAN ROAD                 SE DECISION MADE: 08-MAR-17
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olecranon Plating System
MIAMI DEVICE SOLUTIONS, LLC       510(k) NO: K162898(Traditional)
ATTN: Michelle  Montesino         PHONE NO : 786 4221400 106
7620 NW 25TH STREET UNIT 3        SE DECISION MADE: 17-MAR-17
MIAMI FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SleepWeaver 3D Nasal Mask
Circadiance, LLC                  510(k) NO: K162905(Traditional)
ATTN: JAMES  GIANOUTSOS           PHONE NO : 724 8582837 
1300 RODI RD                      SE DECISION MADE: 15-MAR-17
TURTLE CREEK PA  15145            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexi-Seal PROTECT Fecal Management System
ConvaTec                          510(k) NO: K162906(Traditional)
ATTN: Karen  Howes                PHONE NO : 44 0124 4832195 
GDC, First Avenue, Deeside IndustrSE DECISION MADE: 07-MAR-17
Deeside  GB ch5 2nu               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Male Latex Condoms
Zhejiang Xiangban Latex Products C510(k) NO: K162919(Traditional)
ATTN: Huichao  Lou                PHONE NO : 86 579 85420022 
D288, Huancheng West Road, BeiyuanSE DECISION MADE: 07-MAR-17
Yiwu  CN 322000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated Instrument System
ORTHOFIX INC.                     510(k) NO: K162921(Traditional)
ATTN: JACKI  KOCH                 PHONE NO : 214 9372100 
3451 PLANO PARKWAY                SE DECISION MADE: 13-MAR-17
LEWISVILLE TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid2 Therapy System
MAGSTIM COMPANY LTD.              510(k) NO: K162935(Traditional)
ATTN: Kevyn  Beard                PHONE NO : 44 019 94240798 
SPRING GARDENS                    SE DECISION MADE: 10-MAR-17
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
CHONGQING QMI SURGICAL CO., LTD   510(k) NO: K162947(Traditional)
ATTN: KANG  LI                    PHONE NO : 86 23 67300630 
A ZONE 1ST FLOOR, YANGLIU ROAD NO.SE DECISION MADE: 03-MAR-17
CHONGQING  CN 401121              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TotalC-Ram
ITENA CLINICAL                    510(k) NO: K162960(Abbreviated)
ATTN: Charles  Peyre              PHONE NO : 33 145 913006 
83 AVENUE FOCH                    SE DECISION MADE: 14-MAR-17
PARIS  FR 75116                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: nuance UNIVERSAL
Den-Mat Holdings, LLC             510(k) NO: K162967(Traditional)
ATTN: Helen  Ragus                PHONE NO : 805 3463700 
1017 W. Central Avenue            SE DECISION MADE: 24-MAR-17
Lompoc CA  93436                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veloxion System
Corinth MedTech, Inc.             510(k) NO: K162979(Traditional)
ATTN: Sandeep  Saboo              PHONE NO : 408 9962517 
1601 S. De Anza Blvd. Suite 221   SE DECISION MADE: 24-MAR-17
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ibis® Pedicle Screw System
Ortho Development Corporation     510(k) NO: K162995(Traditional)
ATTN: Lindsay  Martin             PHONE NO : 801 5539991 
12187 South Business Park Drive   SE DECISION MADE: 30-MAR-17
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
MICROVENTION, INC                 510(k) NO: K162999(Traditional)
ATTN: Laraine  Pangelina          PHONE NO : 714 2478150 
1311 VALENCIA AVENUE              SE DECISION MADE: 29-MAR-17
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Y3 Proximal Femoral Plate System
PEGA MEDICAL INC.                 510(k) NO: K163003(Traditional)
ATTN: ARIEL R. DUJOVNE            PHONE NO : 450 6885144 
1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 16-MAR-17
LAVAL  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
GMP MEDICARE SDN BHD              510(k) NO: K163017(Traditional)
ATTN: EVA VINONI BT MUSTAFA       PHONE NO : 60 3 33926317 
LOT/PT64593, JLN DAHLIA/KU8, KAW PSE DECISION MADE: 22-MAR-17
KLANG  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: ORTHOLOC® 3Di Small Bones Plating
Wright Medical Technology, Inc.   510(k) NO: K163039(Traditional)
ATTN: Michael  Mullins            PHONE NO : 901 8674142 
1023 Cherry Road                  SE DECISION MADE: 13-MAR-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brevera Biopsy System with Corlumina Imaging Technology
HOLOGIC, INC.                     510(k) NO: K163052(Traditional)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 2638857 
250 CAMPUS DRIVE                  SE DECISION MADE: 29-MAR-17
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
OSPREY MEDICAL, INC.              510(k) NO: K163054(Traditional)
ATTN: MELANIE  HESS               PHONE NO : 952 9558252 
5600 ROWLAND ROAD SUITE 250       SE DECISION MADE: 08-MAR-17
MINNETONKA MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6200 Ultrasound System and 6250 Ultrasound System
ESAOTE S.P.A                      510(k) NO: K163082(Traditional)
ATTN: MASSIMO  POLIGNANO          PHONE NO : 39 010 65471 
VIA A. SIFFREDI 58                SE DECISION MADE: 16-MAR-17
GENOVA  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Blood Collection Set
Jiangsu Shenli Medical Production 510(k) NO: K163093(Traditional)
ATTN: Tina  Cai                   PHONE NO : 86 519 88731071 
No 20, Changzheng Road, Zhenglu   SE DECISION MADE: 14-MAR-17
Changzhou City  CN 213111         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System
GPC MEDICAL LIMITED               510(k) NO: K163096(Traditional)
ATTN: VIKAS  NARANG               PHONE NO : 91 11 43222600 
GPC SQUARE, M-BLOCK, DDA, LSC, VIKSE DECISION MADE: 31-MAR-17
NEW DELHI  IN 110018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: My Dose Coach
Sanofi, Inc.                      510(k) NO: K163099(Traditional)
ATTN: Robert  Ezzell              PHONE NO : 617 7101418 
640 Memorial Drive                SE DECISION MADE: 22-MAR-17
Cambridge MA  02139               510(k) STATEMENT
                                                    

DEVICE: Tranberg CLS Diffusor Laser Fiber
Clinical Laserthermia Systems AB  510(k) NO: K163103(Special)
ATTN: Lars-Erik  Eriksson         PHONE NO : 464 6152100 
Scheelevagen 2                    SE DECISION MADE: 23-MAR-17
Lund  SE 22381                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OxyHeal 4000 Multiplace Hyperbaric Chamber Family
OXYHEAL MEDICAL SYSTEMS, INC.     510(k) NO: K163109(Special)
ATTN: EDWARD J. CHOMAS            PHONE NO : 619 3362022 
3224 HOOVER AVE                   SE DECISION MADE: 22-MAR-17
NATIONAL CITY CA  91950           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX Microwave Ablation System and Accessories
NEUWAVE MEDICAL, INC.             510(k) NO: K163118(Traditional)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 5121592 
3529 ANDERSON STREET              SE DECISION MADE: 09-MAR-17
MADISON WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROLENE Soft Polypropylene Mesh
Ethicon, Inc.                     510(k) NO: K163152(Traditional)
ATTN: Debbie  Fazen               PHONE NO : 908 2183196 
Route 22 West, P.O. Box 151       SE DECISION MADE: 11-MAR-17
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartGrid
Carestream Health                 510(k) NO: K163157(Traditional)
ATTN: Diane  Koetter              PHONE NO : 585 6276505 
150 Verona Street                 SE DECISION MADE: 21-MAR-17
ROCHESTER NY  14468               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Single-use Syringe with Needle
JiangXi HongDa Medical Equipment G510(k) NO: K163161(Traditional)
ATTN: Yang  Xiaohua               PHONE NO : 86 791 7918562891 
No. 39 South Shengli Road, JinxianSE DECISION MADE: 20-MAR-17
Nanchang  CN 331700               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Safety Syringes for Single Use
JiangXi HongDa Medical Equipment G510(k) NO: K163162(Traditional)
ATTN: Yang  Xiaohua               PHONE NO : 86 21 85628918 
No. 39 South Shengli Road, JinxianSE DECISION MADE: 20-MAR-17
Nanchang  CN 331700               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bel-Cypher Pro
Takara Belmont Corporation        510(k) NO: K163175(Traditional)
ATTN: Toshinori  Kiyomatsu        PHONE NO : 81 6 62135945 
1-1-2 Chome, Higashi-Shinsaibashi,SE DECISION MADE: 20-MAR-17
Osaka  JP 542-0083                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
Medtronic Powered Surgical Solutio510(k) NO: K163182(Traditional)
ATTN: Deep  Pal                   PHONE NO : 817 7886685 
4620 North Beach Street           SE DECISION MADE: 23-MAR-17
Fox Worth TX  76177               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Next Science Wound Gel (Rx)
Next Science, LLC                 510(k) NO: K163188(Traditional)
ATTN: Matthew  Myntti             PHONE NO : 855 5642762 
8130 Baymeadows Way W, Suite 200  SE DECISION MADE: 06-MAR-17
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYMCO EQ10D Scooter
KWANG YANG MOTOR CO., LTD.        510(k) NO: K163201(Traditional)
ATTN: Wang Ching Yun              PHONE NO : 886 7 3822526 
No. 35, Wan Hsing Street, San Min SE DECISION MADE: 16-MAR-17
Kaohsiung  TW 803                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ SOLO Sensor
Jazz Imaging LLC                  510(k) NO: K163224(Traditional)
ATTN: Todd C. Miller              PHONE NO : 650 9990909 
800 Charcot Avenue, Suite 100     SE DECISION MADE: 09-MAR-17
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Modulus XLIF Interbody System
NUVASIVE INCORPORATED             510(k) NO: K163230(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 LUSK BLVD.                   SE DECISION MADE: 16-MAR-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMARTmatic
Kaltenbach & Voigt GmbH           510(k) NO: K163239(Traditional)
ATTN: Stefan  Trampler            PHONE NO : 49 7351 563515 
Bismarckring 39                   SE DECISION MADE: 17-MAR-17
Biberach  DE 88400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
LAURIMED LLC                      510(k) NO: K163247(Traditional)
ATTN: Brian R DuBois              PHONE NO : 650 5875296 
500 ARGUELLO ST., SUITE 100       SE DECISION MADE: 09-MAR-17
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Boston Scientific Corporation     510(k) NO: K163248(Traditional)
ATTN: Yingying  Gao               PHONE NO : 508 6834356 
100 Boston Scientific Way         SE DECISION MADE: 27-MAR-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GoSpiro
MONITORED THERAPEUTICS, INC.      510(k) NO: K163249(Traditional)
ATTN: William  Zimlich            PHONE NO : 614 7613555 
5940 VENTURE DR., SUITE C         SE DECISION MADE: 24-MAR-17
DUBLIN OH  43017                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NITRILE EXAMINATION GLOVE
BRIGHTWAY HOLDINGS SDN BHD        510(k) NO: K163267(Traditional)
ATTN: G.  BASKARAN                PHONE NO : 603 3 3431007 
LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 24-MAR-17
KLANG  MY 42100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo. CT Neuro Perfusion
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163284(Traditional)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 4486477 
40 LIBERTY BLVD. MAIL CODE 65-1A  SE DECISION MADE: 01-MAR-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTIS pheno
SIEMENS MEDICAL SOLUTION USA, INC.510(k) NO: K163286(Traditional)
ATTN: PATRICIA D. JONES           PHONE NO : 610 4486474 
40 LIBERTY BOULEVARD 65-1A        SE DECISION MADE: 09-MAR-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFINITT ULite
INFINITT CO., LTD.                510(k) NO: K163290(Special)
ATTN: Heejin  Lim                 PHONE NO : 82 2 21946923 
12FI Daerung Post Tower III, 27 DiSE DECISION MADE: 24-MAR-17
Seoul  KR 152-746                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM go.Up, SOMATOM go.Now
Siemens Medical Solutions USA, Inc510(k) NO: K163296(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 448 6477
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 21-MAR-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K163297(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd., Mail Code 65-1A SE DECISION MADE: 24-MAR-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermoShield HME Filter
Flexicare Medical Limited         510(k) NO: K163300(Third Party - Traditional)
ATTN: Joel  Biddle                PHONE NO : 44 1443 474647 
Cynon Valley Business Park        SE DECISION MADE: 22-MAR-17
Mountain Ash  GB cf45 4ER         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Expro Elite Snare, Sympro Elite Snare
Vascular Solutions, Inc.          510(k) NO: K163307(Traditional)
ATTN: Jake  Schultz               PHONE NO : 763 6564300 
6464 Sycamore Court North         SE DECISION MADE: 08-MAR-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
Boston Scientific Corporation     510(k) NO: K163314(Traditional)
ATTN: Nikki  Wahlberg             PHONE NO : 763 4942381 
Two Scimed Place                  SE DECISION MADE: 23-MAR-17
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LAP-Pump PP110
W.O.M. WORLD OF MEDICINE GMBH     510(k) NO: K163320(Traditional)
ATTN: Soeren  Markworth           PHONE NO : 0049 30 39981594 
SALZUFER 8                        SE DECISION MADE: 21-MAR-17
Berlin  DE 10587                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphix® External Fixation System MR Conditional
CITIEFFE s.r.l                    510(k) NO: K163323(Traditional)
ATTN: Stefano  Pullega            PHONE NO : 39 051 721850 
Via Armaroli, 21                  SE DECISION MADE: 20-MAR-17
Calderara di Reno  IT 400012      510(k) STATEMENT
                                                    

DEVICE: Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
GE Medical Systems, LLC           510(k) NO: K163331(Traditional)
ATTN: Mary A. Mayka               PHONE NO : 262 5273148 
3200 Grandview Blvd               SE DECISION MADE: 17-MAR-17
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Icare HOME tonometer
Icare Finland Oy                  510(k) NO: K163343(Traditional)
ATTN: Matti  Tulikoura            PHONE NO : 358 9 87751150 
Ayritie 22                        SE DECISION MADE: 21-MAR-17
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAZIC Duro
VERICOM CO., LTD.                 510(k) NO: K163346(Traditional)
ATTN: Myung-Hwan  Oh              PHONE NO : 82 31 4412881 
48 Toegyegongdan 1-gil            SE DECISION MADE: 17-MAR-17
Chuncheon-si  KR 200-944          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multibase Abutments EV and ATLANTIS Suprastructures
DENTSPLY SIRONA                   510(k) NO: K163350(Traditional)
ATTN: KARL  NITTINGER             PHONE NO : 717 8494424 
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 31-MAR-17
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOJAVE Expandable Interbody System
K2M                               510(k) NO: K163364(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 15-MAR-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mikro-Cath Pressure Catheter
Millar, Inc.                      510(k) NO: K163376(Traditional)
ATTN: Jacqueline  Jean-Baptiste   PHONE NO : 832 6677000 
6001-A Gulf Freeway               SE DECISION MADE: 10-MAR-17
Houston TX  77023                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monarch Airway Clearance System
HILL-ROM SERVICES PTE LTD         510(k) NO: K163378(Traditional)
ATTN: Huifang  Zhu                PHONE NO : 65 6 4997395 
1 YISHUN AVE 7                    SE DECISION MADE: 17-MAR-17
Singapore  SG                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KneeAlign 2 System
OrthAlign, Inc.                   510(k) NO: K163379(Traditional)
ATTN: David  Vancelette           PHONE NO : 949 7152424 
120 Columbia, Suite 500           SE DECISION MADE: 02-MAR-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nix Ultra Lice Treatment Kit
MEDTECH PRODUCTS INC.             510(k) NO: K163401(Traditional)
ATTN: JEAN  BOYKO                 PHONE NO : 914 5246894 
660 WHITE PLAINS ROAD             SE DECISION MADE: 21-MAR-17
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 360KS Implant Positioning System
Kico Knee Innovation Company PTY L510(k) NO: K163405(Traditional)
ATTN: Karl  Rentsch               PHONE NO : 61 408 419070 
Suite 3, Building 1, 20 Bridge StrSE DECISION MADE: 21-MAR-17
Pymble  AU 2073                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart(TM) T Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K163409(Traditional)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street North, Suite 600  SE DECISION MADE: 08-MAR-17
St. Paul MN  55128-5455           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
NARANG MEDICAL USA CORPORATION    510(k) NO: K163425(Traditional)
ATTN: Reginald  Swift             PHONE NO : 978 6556770 
15951 SW 41 ST SUITE 800B         SE DECISION MADE: 24-MAR-17
DAVIE FL  33331                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Greiner Vacuette Urine Count and Culture, Mannitol tube
GREINER BIO-ONE NA INC.           510(k) NO: K163436(Traditional)
ATTN: MANFRED  ABEL               PHONE NO : 704 2617823 
4238 CAPITAL DRIVE                SE DECISION MADE: 06-MAR-17
MONROE NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIVA combo RF System
STARmed Co., Ltd.                 510(k) NO: K163450(Traditional)
ATTN: Jun-Young  Jung             PHONE NO : 82 70 46738628 
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 08-MAR-17
Gyeonggi-do  KR 10355             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kalitec Direct InSePtion™ MIS Fixation System
KALITEC DIRECT, LLC               510(k) NO: K163471(Traditional)
ATTN: KEITH  CANNAN               PHONE NO : 407 5452063 103
618 E. SOUTH STREET SUITE 500     SE DECISION MADE: 16-MAR-17
ORLANDO FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAVUX CervicalCage-L SA System
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K163474(Traditional)
ATTN: EDWARD  LIOU                PHONE NO : 415 9239376 
1331 N. CALIFORNIA BLVD SUITE 320 SE DECISION MADE: 10-MAR-17
WALNUT CREEK CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex-Thread Clavicle Pin System
INTRAFUSE LLC                     510(k) NO: K163488(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 S 600W, SUITE 100             SE DECISION MADE: 20-MAR-17
LOGAN UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoSolutions 'System26' Bone Screws
Ortho SOlutions UK Limited        510(k) NO: K163489(Traditional)
ATTN: Craig  Bluett               PHONE NO : 016 21 843599 
West Station Business Park, SpitalSE DECISION MADE: 08-MAR-17
Maldon  GB CM9 6FF                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive CoRoent Small Interbody System
NuVasive, Incorporated            510(k) NO: K163491(Traditional)
ATTN: Martin  Yahiro              PHONE NO : 858 6385589 
7475 Lusk Boulevard               SE DECISION MADE: 24-MAR-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AdvanCE capsule endoscope delivery device
United States Endoscopy Group, Inc510(k) NO: K163495(Traditional)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 10-MAR-17
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
ENCORE MEDICAL, L.P.              510(k) NO: K163497(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 METRIC BLVD.                 SE DECISION MADE: 02-MAR-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALIDATE Heparin Calibration Verification/Linearity Test Kit
MAINE STANDARDS COMPANY, LLC      510(k) NO: K163498(Traditional)
ATTN: JAMES  CHAMPLIN             PHONE NO : 207 8921300 
221 US Route 1                    SE DECISION MADE: 16-MAR-17
Cumberland Foreside ME  04110     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
LIOFILCHEM S.R.L.                 510(k) NO: K163517(Traditional)
ATTN: FABIO  BROCCO               PHONE NO : 39 085 8930745 
VIA SCOZIA ZONA IND. LE           SE DECISION MADE: 14-MAR-17
ROSETO DEGLI ABRUZZI  IT 64026    510(k) STATEMENT
                                                    

DEVICE: FilmArray Warrior Control Panel M290
Maine Molecular Quality Controls, 510(k) NO: K163522(Traditional)
ATTN: Joan  Gordon                PHONE NO : 207 8851072 
23 Mill Brook Road                SE DECISION MADE: 14-MAR-17
Saco ME  04072                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HITACHI Supria Whole-body X-ray CT System Phase 3
Hitachi Medical Systems America, I510(k) NO: K163528(Abbreviated)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 03-MAR-17
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
AVERY DENNISON CORPORATION        510(k) NO: K163529(Traditional)
ATTN: LISA  BARTAKOVICS           PHONE NO : 440 5346000 
7100 Lindsay Dr Bldg 14           SE DECISION MADE: 29-MAR-17
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iPulse SmoothSkin BARE Hair Removal Device
CYDEN LIMITED                     510(k) NO: K163552(Special)
ATTN: MIKE  KIERNAN               PHONE NO : 44 179 2485519 
TECHNIUM 2, KINGS ROAD            SE DECISION MADE: 03-MAR-17
SWANSEA  GB SA1 8PJ               510(k) STATEMENT
                                                    

DEVICE: Synapsys Ulmer Video Nystagmograph
Synapsys SA                       510(k) NO: K163558(Special)
ATTN: Laetitia  Baconnier         PHONE NO : 33 4 91117575 
                                  SE DECISION MADE: 23-MAR-17
Marseille  FR 13013               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Gentamicin (<=1 –="">=16 µg/mL)
bioMerieux, Inc                   510(k) NO: K163563(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 13-MAR-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR8 Drill System
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K163565(Traditional)
ATTN: Deep  Pal                   PHONE NO : 817 7886400 
4620 NORTH BEACH ST.              SE DECISION MADE: 28-MAR-17
FORT WORTH TX  76137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys CMV IgM
Roche Diagnostics                 510(k) NO: K163569(Traditional)
ATTN: Angelo  Pereira             PHONE NO : 317 5213544 
9115 Hague Rd.                    SE DECISION MADE: 17-MAR-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
LV Liberty Vision Corp.           510(k) NO: K163572(Traditional)
ATTN: Paul T. Finger              PHONE NO : 603 7660451 
155 Fleet Street                  SE DECISION MADE: 15-MAR-17
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inqwire Diagnostic Guide Wire
Merit Medical Systems, Inc.       510(k) NO: K163575(Special)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 03-MAR-17
Galway  IE N-A                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
TrovRx, Inc. dba Trovita Health Sc510(k) NO: K163586(Traditional)
ATTN: William  Brown              PHONE NO : 908 9387534 
230 South Broad Street, 17th FloorSE DECISION MADE: 17-MAR-17
Philadelphia PA  19102            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Incubator for Assert Self Contained Biological Indicators
STERIS Corporation                510(k) NO: K163587(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5976 Heisley Rd                   SE DECISION MADE: 24-MAR-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine® Daytona® Small Stature Spinal System
SeaSpine Orthopedics Corporation  510(k) NO: K163604(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 09-MAR-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
BioStable Science & Engineering In510(k) NO: K163608(Traditional)
ATTN: Julie  Thomas               PHONE NO : 512 9709112 
2621 Ridgepoint Dr., Suite 100    SE DECISION MADE: 21-MAR-17
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Audit MicroControls Linearity FD Tumor Markers II
Aalto Scientific, Ltd.            510(k) NO: K163629(Traditional)
ATTN: Robert  Burda               PHONE NO : 760 4317922 
230 Technology Parkway            SE DECISION MADE: 10-MAR-17
Eatonton GA  31024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)
BECTON, DICKINSON & COMPANY       510(k) NO: K163637(Traditional)
ATTN: MONICA E. GIGUERE           PHONE NO : 410 3164287 
7 LOVETON CIRCLE MC 694           SE DECISION MADE: 21-MAR-17
SPARKS MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureSigns VS3; SureSigns VS4
Philips Medical Systems           510(k) NO: K163649(Special)
ATTN: Greg  Li                    PHONE NO : 978 6594227 
3000 Minuteman Rd.                SE DECISION MADE: 31-MAR-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
Covidien llc                      510(k) NO: K163654(Traditional)
ATTN: Gary  LeMere                PHONE NO : 203 4925572 
60 Middletown Avenue              SE DECISION MADE: 08-MAR-17
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sparkling
Shanghai Wonderful Opto-Electrics 510(k) NO: K163655(Traditional)
ATTN: Amy  Lee                    PHONE NO : 0086 21 62642623 
2F, Building 3, Lane 561, Nujiang SE DECISION MADE: 17-MAR-17
Shanghai  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bodycad Unicompartmental Knee System
Bodycad Laboratories, Inc.        510(k) NO: K163700(Traditional)
ATTN: Marc  Chaunet               PHONE NO : 418 5271388 
2035, rue du Haut-Bord            SE DECISION MADE: 29-MAR-17
Quebec City  CA g1n 4rY           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophageal Cooling Device
ADVANCED COOLING THERAPY, LLC     510(k) NO: K170009(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 312 7254756 
3440 S. Dearborn St. #215-South   SE DECISION MADE: 30-MAR-17
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVATECH TALCAIR
NOVATECH S.A.                     510(k) NO: K170030(Traditional)
ATTN: JENNIFER  NEFF              PHONE NO : 33 044 2981560 
Z.I. ATHELIA III - 1058, VOIE ANTISE DECISION MADE: 13-MAR-17
LA CIOTAT CEDEX  FR 13705         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TheraView TBI
Cablon  Medical B.V.              510(k) NO: K170058(Special)
ATTN: Jurjen  Weistra             PHONE NO : 31 33 4943964 
Klepelhoek 11                     SE DECISION MADE: 03-MAR-17
Leusden  NL 3833 GZ               510(k) STATEMENT
                                                    

DEVICE: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
Siemens Healthcare Diagnostics, In510(k) NO: K170065(Traditional)
ATTN: Julie  Warren               PHONE NO : 302 6318722 
511 Benedict Avenue               SE DECISION MADE: 09-MAR-17
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUOFUCON Silicone Ag Foam Dressing with Border
HUIZHOU FORYOU MEDICAL DEVICES Co.510(k) NO: K170077(Traditional)
ATTN: Guosheng  Tan               PHONE NO : 86 0752 5302012 
NORTH SHANGXIA ROAD DONGJIANG HI-TSE DECISION MADE: 30-MAR-17
HUIZHOU  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InterLock Trocar
FUJIFILM New Development U.S.A., I510(k) NO: K170084(Traditional)
ATTN: Stephen  Mariano            PHONE NO : 781 8602463 
318 Bear Hill Road, Suite 10      SE DECISION MADE: 10-MAR-17
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vial2Bag Direct Connect
Medimop Medical Project Ltd.      510(k) NO: K170095(Special)
ATTN: Ilanit  Goldgraber          PHONE NO : 972 9 7757122 
17 Hatidhar St.                   SE DECISION MADE: 08-MAR-17
Ra'anana  IL 43665                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICONIX TT All Suture Anchor
Stryker                           510(k) NO: K170098(Special)
ATTN: Taylor  White               PHONE NO : 303 3367285 
5670 Greenwood Plaza Blvd., Suite SE DECISION MADE: 31-MAR-17
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermi Injectable RF Electrodes
Thermi                            510(k) NO: K170116(Traditional)
ATTN: Suzanne  Cheang             PHONE NO : 214 8880683 
8304 Esters Boulevard             SE DECISION MADE: 13-MAR-17
IRVING TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Level One Hand Plating System
KLS MARTIN LP                     510(k) NO: K170124(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 09-MAR-17
JACKSONVILLE FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Reline® 4.5-5.0 System
NUVASIVE, INCORPORATED            510(k) NO: K170126(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3205488 
7475 LUSK BLVD.                   SE DECISION MADE: 09-MAR-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
Hardy Diagnostics                 510(k) NO: K170127(Traditional)
ATTN: Rianna  Malherbe            PHONE NO : 805 3462766 5714
1430 West McCoy Lane              SE DECISION MADE: 14-MAR-17
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: New Deantronics E Green™ Electrosurgical Monopolar Pencils
New Deantronics  Taiwan, LTD      510(k) NO: K170161(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F,No.51,Sec.4, Chong Yang Road, SE DECISION MADE: 29-MAR-17
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D OCT-1 Maestro
Topcon Corporation                510(k) NO: K170164(Special)
ATTN: James  Lorkowski            PHONE NO : 201 5995283 
75-1 Hasunuma-cho, Itabashi-ku    SE DECISION MADE: 03-MAR-17
Tokyo  JP 174-8580                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True 3D Viewer Software
EchoPixel Inc.                    510(k) NO: K170167(Third Party - Special)
ATTN: Sergio  Aguirre             PHONE NO : 650 4047097 
2490 Hospital Drive, Suite 310    SE DECISION MADE: 03-MAR-17
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
Bovie Medical Corporation         510(k) NO: K170188(Traditional)
ATTN: Rubiela  Maldonado          PHONE NO : 727 8038508 
5115 Ulmerton Road                SE DECISION MADE: 08-MAR-17
Clearwater FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FFR Link, FFR Signal Processing Module
Boston Scientific Corporation     510(k) NO: K170204(Traditional)
ATTN: Dan  Krause                 PHONE NO : 510 2400048 
47215 Lakeview Blvd.              SE DECISION MADE: 24-MAR-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOSPA IS TLIF & DLIF Cages
CORENTEC CO., LTD                 510(k) NO: K170243(Special)
ATTN: J.S.  DANIEL                PHONE NO : 82 415 857144 
12, YEONGSANHONG 1-GIL, IPJANG-MYESE DECISION MADE: 31-MAR-17
Cheonan-si  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BGM009 Plus Blood Glucose Monitoring System
Apex Bio Technology Corp.         510(k) NO: K170267(Special)
ATTN: Hsue-mei  Lee               PHONE NO : 011 886 35641952 
No. 7, Li-Hsin Road V Hsinchu ScieSE DECISION MADE: 09-MAR-17
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive(r) Monolith Corpectomy System
NuVasive, Incorporated            510(k) NO: K170271(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Boulevard               SE DECISION MADE: 30-MAR-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K170277(Traditional)
ATTN: YANG  ZHAOHUI               PHONE NO : 86 755 81885640 
KEJI 12TH ROAD SOUTH, HI-TECH INDUSE DECISION MADE: 23-MAR-17
SHENZHEN  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Great Basin Bordetella Direct Test
GREAT BASIN SCIENTIFIC, INC.      510(k) NO: K170284(Traditional)
ATTN: SUZETTE  CHANCE             PHONE NO : 385 2153369 
2441 S. 3850 WEST SUITE 100       SE DECISION MADE: 31-MAR-17
SALT LAKE CITY UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreCath 2.7S
Medtronic Advanced Energy         510(k) NO: K170296(Traditional)
ATTN: Lydia  Sakakeeny            PHONE NO : 603 2945482 
180 International Drive           SE DECISION MADE: 20-MAR-17
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alians Clavicle range
Newclip Technics                  510(k) NO: K170310(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 30-MAR-17
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACL AcuStar
INSTRUMENTATION LABORATORY CO.    510(k) NO: K170314(Special)
ATTN: NIKITA  MALLADI             PHONE NO : 781 6743245 
180 HARTWELL ROAD                 SE DECISION MADE: 03-MAR-17
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus SLiK Anchors
Parcus Medical                    510(k) NO: K170327(Traditional)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 30-MAR-17
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Basic, Dominant Flex
Modela AG                         510(k) NO: K170329(Traditional)
ATTN: Markus  Butler              PHONE NO : 41 041 5616671 
Lattichstrasse 4b                 SE DECISION MADE: 24-MAR-17
Baar  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cyber Ho
quanta system spa                 510(k) NO: K170331(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 033 1376797 
via acquedotto 109                SE DECISION MADE: 03-MAR-17
samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Canon, Inc.                       510(k) NO: K170332(Traditional)
ATTN: SHINJI  MORI                PHONE NO : 81 3 37582111 
9-1, Imaikami-Cho                 SE DECISION MADE: 01-MAR-17
NAKAHARA-ku, KAWASAKI  JP 211-8501510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
Valley Contax, Inc.               510(k) NO: K170335(Traditional)
ATTN: Josh  Adams                 PHONE NO : 800 5478815___ 
200 S Mill St                     SE DECISION MADE: 24-MAR-17
Springfield OR  97477             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
Becton, Dickinson and Company     510(k) NO: K170336(Third Party - Traditional)
ATTN: Kimberly  Geisler           PHONE NO : 801 5652300 
9450 South State Street           SE DECISION MADE: 10-MAR-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PRECICE Intramedullary Limb Lengthening System
NuVasive Specialized Orthopedics, 510(k) NO: K170346(Traditional)
ATTN: Lance  Justice              PHONE NO : 949 8373600 
101 Enterprise, Suite 100         SE DECISION MADE: 07-MAR-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signia Four-Bay Smart Charger (to be used with Signia Stapler)
Covidien                          510(k) NO: K170348(Special)
ATTN: Katherine Y. Choi           PHONE NO : 203 4928412 
60 Middletown Avenue              SE DECISION MADE: 02-MAR-17
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToeMATE® Hammertoe Correction System
Arthrosurface, Inc.               510(k) NO: K170350(Special)
ATTN: Phani  Puppala              PHONE NO : 508 5203003 
28 Forge Parkway                  SE DECISION MADE: 03-MAR-17
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation 6
RaySearch Laboratories AB (publ)  510(k) NO: K170355(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 722 366110 
Sveav 44                          SE DECISION MADE: 02-MAR-17
Stockholm  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANSiStim-PP
DyAnsys Inc                       510(k) NO: K170391(Special)
ATTN: Srini  Nageshwar            PHONE NO : 408 4804700 
300, North Bayshore Boulevard     SE DECISION MADE: 09-MAR-17
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CenterCross Ultra LV Catheter
Roxwood Medical, Inc.             510(k) NO: K170403(Special)
ATTN: Mehrdad  Farhangnia         PHONE NO : 408 3734751 
400 Seaport Ct, Suite 103         SE DECISION MADE: 07-MAR-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: n!ce Glass Ceramic Blocks for Amann Girrbach
Institut Straumann AG             510(k) NO: K170420(Special)
ATTN: Christopher  Klaczyk        PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 02-MAR-17
Basel  CH                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSolution One Surgical System Model 210
THINK Surgical Inc.               510(k) NO: K170430(Special)
ATTN: In K. Mun                   PHONE NO : 510 2492300 
47320 Mission Falls Court         SE DECISION MADE: 06-MAR-17
Fremont CA  94539                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
Millennium Medical Technologies, I510(k) NO: K170449(Traditional)
ATTN: Jim  Barley                 PHONE NO : 949 4333058 
6352 Corte Del Abeto Suite A      SE DECISION MADE: 31-MAR-17
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDX Console (DR-ID300CL) Software
FUJIFILM Medical Systems U.S.A., I510(k) NO: K170451(Traditional)
ATTN: Peter  Altman               PHONE NO : 203 6023576 
419 West Avenue                   SE DECISION MADE: 16-MAR-17
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLIF Anterior Stand Alone
Medacta International SA          510(k) NO: K170455(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 16-MAR-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nio Color 5.8MP (MDNC-6121)
Barco NV                          510(k) NO: K170476(Special)
ATTN: Helena  Soenen              PHONE NO : 32 56 233528 
President Kennedypark 35          SE DECISION MADE: 28-MAR-17
Kortrijk  BE 8500                 510(k) STATEMENT
                                                    

DEVICE: HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K170493(Third Party - Traditional)
ATTN: Jiyeon  Cho                 PHONE NO : 82 2 21945431 
42, Teheran-ro 108-gil, Gangnam-guSE DECISION MADE: 28-MAR-17
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
ConMed Corporation                510(k) NO: K170501(Special)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 17-MAR-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
Intuitive Surgical, Inc.          510(k) NO: K170508(Traditional)
ATTN: Cheryl  Wu                  PHONE NO : 408 5236401 
1266 Kifer Road                   SE DECISION MADE: 10-MAR-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Titanium Interbody Fusion System
Altus Partners, LLC               510(k) NO: K170512(Special)
ATTN: Claudia  Hill               PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 10-MAR-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Alcon Research, Ltd.              510(k) NO: K170520(Special)
ATTN: Karen  Mudd                 PHONE NO : 949 5057269 
20511 Lake Forest Drive           SE DECISION MADE: 22-MAR-17
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterispine™ PS
SAFE ORTHOPAEDICS                 510(k) NO: K170528(Special)
ATTN: Pierre  Dumouchel           PHONE NO : 330 134 215000 
PARC DES BELLEVUES Allee R. LuxembSE DECISION MADE: 09-MAR-17
Eragny Sur Oise  FR 95610         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Butrex Lumbar Buttress Plating System
X-Spine Systems, Inc.             510(k) NO: K170530(Special)
ATTN: Kriss  Anderson             PHONE NO : 937 8478400 2137
452 Alexandersville Rd            SE DECISION MADE: 22-MAR-17
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
Avitus Orthopaedics, Inc          510(k) NO: K170539(Special)
ATTN: Maxim  Budyansky            PHONE NO : 860 4046476 
400 Farmington Ave Suite R2826, CBSE DECISION MADE: 20-MAR-17
Farmington CT  06032              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Medtronic, Inc.                   510(k) NO: K170583(Special)
ATTN: Gayatri  Ghadge             PHONE NO : 763 5269336 
7611 Northland Drive              SE DECISION MADE: 17-MAR-17
Minneapolis MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
Cook Incorporated                 510(k) NO: K170622(Special)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3392235 104371
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 31-MAR-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioMonitor 2-AF, BioMonitor 2-S
BIOTRONIK, Inc                    510(k) NO: K170628(Special)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 31-MAR-17
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chameleon PTA Balloon Catheter
AV Medical Technologies Ltd       510(k) NO: K170635(Special)
ATTN: Limor  Sandach              PHONE NO : 972 775 055645 
21 B Habarzel Street              SE DECISION MADE: 30-MAR-17
Tel-Aviv  IL 6971029              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fathom-16 Steerable Guidewires
Boston Scientific Corporation     510(k) NO: K170636(Special)
ATTN: Keith  Neligan              PHONE NO : 00353 21 4531786 
Three Scimed Place                SE DECISION MADE: 22-MAR-17
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: USS System
Synthes USA Products LLC          510(k) NO: K170654(Special)
ATTN: Eugene  Bang                PHONE NO : 508 9773966 
325 Paramount Drive               SE DECISION MADE: 29-MAR-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEN_2 and GEN_3 Mechanical Wheelchairs
Free Wheelchair Mission           510(k) NO: K170701(Special)
ATTN: Don  Schoendorfer           PHONE NO : 949 2738470 
15279 Alton Parkway Suite 300     SE DECISION MADE: 24-MAR-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AngioDynamics Total Abscession Biliary Drainage Catheter
AngioDynamics, Inc.               510(k) NO: K170743(Special)
ATTN: Teri  Juckett               PHONE NO : 518 7951142 
603 Queensbury Avenue             SE DECISION MADE: 30-MAR-17
Queensbury NY  12804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CX50N(CX50YQS)
WIDE Corporation                  510(k) NO: K170783(Traditional)
ATTN: YeoJin  Yun                 PHONE NO : 82 312 181675 
12 Wongomae-Ro, Giheung-Gu        SE DECISION MADE: 31-MAR-17
Yongin-Si  KR 17086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


          TOTAL 510(k)s THIS PERIOD   272                                     
          TOTAL WITH SUMMARIES        251                                     
          TOTAL WITH STATEMENTS        21