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  1. 510(k) Clearances

August 2018 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2018


DEVICE: EasyTouch Safety Pen Needle
MHC Medical Products, LLC.        510(k) NO: K163578(Traditional)
ATTN: John  Edmiston              PHONE NO : 513 3542642 
8695 Seward Road                  SE DECISION MADE: 03-AUG-18
Fairfield OH  45011               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-CAD smile
Metoxit AG                        510(k) NO: K170050(Traditional)
ATTN: Dipl.-Ing Stefan Leyen      PHONE NO : 41 52 6450101 
Emdwiesenstrasse 6                SE DECISION MADE: 23-AUG-18
Thayngen  CH CH-8240              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diana Medication Transfer Set
ICU MEDICAL INC                   510(k) NO: K170110(Traditional)
ATTN: Jason  Ma                   PHONE NO : 224 7062411 
951 CALLE AMANECER                SE DECISION MADE: 10-AUG-18
SAN CLEMENTE CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Vacutainer Eclipse Signal Blood Collection Needle
Becton, Dickinson and Company     510(k) NO: K170824(Traditional)
ATTN: Eileen  Hiller              PHONE NO : 208 8474570 
1 Becton Drive                    SE DECISION MADE: 20-AUG-18
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Presygen/si-1
Christie Medical Holdings, Inc.   510(k) NO: K171245(Traditional)
ATTN: Salwa  Rezk                 PHONE NO : 519 7413794 
3175 Lenox Park Boulevard, Suite 2SE DECISION MADE: 09-AUG-18
Memphis TN  38115                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Young INFINITY Cordless Handpiece System
Young Dental Manufacturing Co 1, L510(k) NO: K171377(Traditional)
ATTN: Brian  Prange               PHONE NO : 314 3728054 
13705 Shoreline CtEast            SE DECISION MADE: 20-AUG-18
Earth City MO  63045              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VirtuOst Vertebral Fracture Assessment
O.N. Diagnostics, LLC.            510(k) NO: K171435(Traditional)
ATTN: David  Kopperdahl           PHONE NO : 510 2040688 
2150 Shattuck Ave. Suite 610      SE DECISION MADE: 03-AUG-18
Berkeley CA  94704                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qualisys Clinical System
Qualisys AB                       510(k) NO: K171547(Traditional)
ATTN: Henrik  Wiberg              PHONE NO : 46 31 3369400 
Kvarnbergsgatan 2                 SE DECISION MADE: 02-AUG-18
Goteborg  SE 411 05               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelligent Mesh Nebulizer
Qingdao Future Medical Technology 510(k) NO: K171549(Traditional)
ATTN: Wang  WeiLai                PHONE NO : 86 1866 9802350 
Room 401 Building F, No. 169 ZhuzhSE DECISION MADE: 31-AUG-18
QingDao  CN 266001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEXCORE Breast Biopsy System, Biopsy Needle
Medical Park CO., LTD             510(k) NO: K171890(Traditional)
ATTN: Hye-Yeon  Park              PHONE NO : 82 70 48006532 
#624, Knowlegdge Industry Center BSE DECISION MADE: 20-AUG-18
Yongin-si  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
Hinacom Software and Technology, L510(k) NO: K171977(Traditional)
ATTN: Yi Isabelle Sun             PHONE NO : 86 106 2701653 
Suite B301, R&D Plaza, Tsinghua scSE DECISION MADE: 02-AUG-18
Beijing  CN 100084                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BH Sterilization Pouch
BH Medical Products Co., Ltd.     510(k) NO: K172280(Traditional)
ATTN: Edward  Tao                 PHONE NO : 086 519 83978705 
No.90 Shenjiang Villagers Group, ZSE DECISION MADE: 03-AUG-18
Changzhou  CN 213024              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optical Topography System ETG-4100
Hitachi Healthcare Americas       510(k) NO: K172492(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 3720
1959 Summit Commerce Park         SE DECISION MADE: 17-AUG-18
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ageless Health Medical Digital Thermometer
Ageless Health Industrial Co., Ltd510(k) NO: K172508(Traditional)
ATTN: Victor  Wan                 PHONE NO : 86 769 81158038 
3/F, A1 Bldg, Dongshen Sima IndustSE DECISION MADE: 08-AUG-18
Dongguan  CN 523000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Double Medical Femoral Nail System
Double Medical Technology Inc.    510(k) NO: K172830(Traditional)
ATTN: Yan  Zuo                    PHONE NO : 86 592 6087671 
No. 18, Shanbianhong East Road, HaSE DECISION MADE: 24-AUG-18
Xiamen  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
OsteoRemedies, LLC                510(k) NO: K172906(Traditional)
ATTN: Eric  Stookey               PHONE NO : 901 4533141 
6800 Poplar Avenue, #120          SE DECISION MADE: 29-AUG-18
Germantown TN  38138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-invasive blood pressure measurement systems
Joytech Healthcare Co.,Ltd        510(k) NO: K173024(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No. 365 Wuzhou Road, Yuhang EconomSE DECISION MADE: 22-AUG-18
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
Edan Instruments, Inc             510(k) NO: K173042(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 28340011 
#15 Jinhui Road, Jinsha Community SE DECISION MADE: 30-AUG-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shenzhen IMDK Medical Technology C510(k) NO: K173123(Traditional)
ATTN: Xia  Yuan                   PHONE NO : 86 755 36637905 
C Zone, 10F, Building 16, YuanshanSE DECISION MADE: 13-AUG-18
Guangming District, Shenzhen  CN  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: F&P SleepStyle
Fisher & Paykel Healthcare Ltd    510(k) NO: K173193(Traditional)
ATTN: Jayanti  Karandikar         PHONE NO : 64 574 0100 
15 Maurice Paykel Place           SE DECISION MADE: 08-AUG-18
East Tamaki  NZ 2013              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable NIBP Cuff
Orantech Inc.                     510(k) NO: K173197(Traditional)
ATTN: Yunxi  Xiong                PHONE NO : 86 755 23699939 
Zone#A, 4F, 1st Bld, 7th IndustriaSE DECISION MADE: 21-AUG-18
Guangming New District, Shenzhen  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Equinox Advantage
O-Two Medical Technologies Inc.   510(k) NO: K173205(Traditional)
ATTN: David  Zhang                PHONE NO : 1 905 7926896 
45A Armthorpe Road                SE DECISION MADE: 29-AUG-18
Brampton  CA L6T 5M4              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOSKIN
Bioserenity SAS                   510(k) NO: K173248(Traditional)
ATTN: Quang  Tran                 PHONE NO : 331 57 274456 
47 boulevard de l'Hopital         SE DECISION MADE: 11-AUG-18
Paris  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTI Dental Implant System UnicCa
B.T.I. Biotechnology Institute, S.510(k) NO: K173257(Traditional)
ATTN: Fernanda O Ros              PHONE NO : 34 945 297030 
Leaonardo Da Vinci 14 Parque TecnoSE DECISION MADE: 17-AUG-18
Minano  ES 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neonatal ConchaSmart Breathing Circuits
Teleflex Medical, Inc             510(k) NO: K173280(Traditional)
ATTN: Brian  Gall                 PHONE NO : 919 2284350 
3015 Carrington Mill Blvd-6N      SE DECISION MADE: 02-AUG-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable & Disposable SpO2 Sensors
Shenzhen Coreray Technology, Ltd. 510(k) NO: K173368(Traditional)
ATTN: Simon  Fan                  PHONE NO : 86 755 28239229 
ChuangYe Technology Park 1th Dong SE DECISION MADE: 31-AUG-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: b-ONE® Total Hip System
b-One Ortho Corp.                 510(k) NO: K173380(Traditional)
ATTN: Clark  Hutton               PHONE NO : 949 2448162 
3 Wing Drive Suite #259           SE DECISION MADE: 30-AUG-18
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VT - 100, VT - 200
Carilex Medical, Inc.             510(k) NO: K173407(Traditional)
ATTN: Henry  Kao                  PHONE NO : 886 3 3287882 
No. 77 Keji 1st Rd., Guishan Dist.SE DECISION MADE: 09-AUG-18
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-parameter Patient Monitor, models C30
Shenzhen Comen Medical Instruments510(k) NO: K173454(Traditional)
ATTN: Hongbo  Yan                 PHONE NO : 86 134 24152596 
South of Floor 7, BLock 5 4th InduSE DECISION MADE: 16-AUG-18
Shenzhen  CN 518052               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG recorder and Arrhythmia Detector
Smart Solutions Technologies  SL  510(k) NO: K173461(Traditional)
ATTN: Daniel  Llorca              PHONE NO : 34 91 3604431 
Calle Toronga 21, Local 1         SE DECISION MADE: 03-AUG-18
Madrid  ES 28015                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
ICU Medical, Inc.                 510(k) NO: K173477(Traditional)
ATTN: Catherine E. Kang           PHONE NO : 224 7062372 
600 N. Field Drive                SE DECISION MADE: 31-AUG-18
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia 2 Lyme FIA, Sofia Lyme Control Set
Quidel Corporation                510(k) NO: K173496(Dual Track)
ATTN: Jennifer S. Rial            PHONE NO : 858 5527910 
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 30-AUG-18
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
DiaSorin Molecular LLC            510(k) NO: K173498(Traditional)
ATTN: Sharon  Young               PHONE NO : 562 2406680 
11331 Valley View Street          SE DECISION MADE: 13-AUG-18
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORA GTel Blood Glucose Monitoring System
ForaCare Inc.                     510(k) NO: K173505(Traditional)
ATTN: Anne  Kuo                   PHONE NO : 805 4988188 
893 Patriot Dr. Suite D           SE DECISION MADE: 09-AUG-18
Moorpark CA  93021                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodegradable Nitrile Powder Free Examination Glove (Blue)
Hartalega Sdn. Bhd.               510(k) NO: K173509(Traditional)
ATTN: Kuan Kam Hon                PHONE NO : 603 62771733 
Dataran SD PJU 9                  SE DECISION MADE: 17-AUG-18
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: NuBorne Infant Warmer
International Biomedical          510(k) NO: K173516(Abbreviated)
ATTN: Amy  Pieper                 PHONE NO : 512 8730033 231
8206 Cross Park Drive             SE DECISION MADE: 17-AUG-18
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lockbox for Perfusor Space PCA Infusion Pump
B. Braun Medical Inc.             510(k) NO: K173531(Traditional)
ATTN: Tracy  Maddock              PHONE NO : 610 5962545 
901 Marcon Blvd                   SE DECISION MADE: 02-AUG-18
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPINAUT
Imedicom Co., Ltd.                510(k) NO: K173541(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 
#612, 172, LS-ro                  SE DECISION MADE: 24-AUG-18
Gunpo-si  KR 435824               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIAFINE
Valeant Pharmaceuticals           510(k) NO: K173549(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 585 3386045 
1400 North Goodman Street         SE DECISION MADE: 13-AUG-18
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoReady Dental Implant System
OsteoReady LLC                    510(k) NO: K173575(Traditional)
ATTN: Robert  Gottlander          PHONE NO : 206 8127727 
150 Baker Ave. Ext. Ste. 110      SE DECISION MADE: 17-AUG-18
Concord MA  01742                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Forest Dental Unit
Forest Dental Products, Inc.      510(k) NO: K173608(Traditional)
ATTN: Erin-Kate  Barton           PHONE NO : 971 3279024 
6200 NE Cherry Drive              SE DECISION MADE: 17-AUG-18
Hillsboro OR  97124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mag Vita TMS Therapy System w/Theta Burst Stimulation
Tonica Elektronik A/S             510(k) NO: K173620(Traditional)
ATTN: Sanne Barsballe Jessen      PHONE NO : 45 44 998444 
Lucernemarken 15                  SE DECISION MADE: 14-AUG-18
Farum  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchor plate
BioMaterials Korea, Inc           510(k) NO: K173623(Traditional)
ATTN: Jiyea  Kim                  PHONE NO : 82 31 7904511 
#413, #329, #331 150, Jojeong-daerSE DECISION MADE: 30-AUG-18
Hanam-si  KR 12930                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
Bionime Corporation               510(k) NO: K173638(Traditional)
ATTN: Kay  Wu                     PHONE NO : 886 4 23692388 
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 17-AUG-18
Taichung  TW 40242                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectralis HRA + OCT and variants
Heidelberg Engineering GmbH       510(k) NO: K173648(Traditional)
ATTN: Christoph  Schoess          PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 30-AUG-18
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
Cook Incorporated                 510(k) NO: K173657(Traditional)
ATTN: Samuel  Engelman            PHONE NO : 812 3393235 104340
750 Daniels Way                   SE DECISION MADE: 23-AUG-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Confidence Blood Glucose Monitoring System
Applied Biomedical LLC            510(k) NO: K173658(Traditional)
ATTN: Zakir  Murtaza              PHONE NO : 714 6463233 
1981 E Miraloma Ave., Unit B      SE DECISION MADE: 21-AUG-18
Placentia CA  92870               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Stethoscope DS3011A
IMEDIPLUS INC.                    510(k) NO: K173663(Abbreviated)
ATTN: Shirley  Lai                PHONE NO : 886 3658 7700 
2F, 12, Shengyi Rd.Sec.2          SE DECISION MADE: 17-AUG-18
Chupei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcuSnare Polypectomy Snare
Wilson-Cook Medical, Inc          510(k) NO: K173673(Traditional)
ATTN: Theresa  de Prat            PHONE NO : 336 7440157 396518
4900 Bethania Station Road        SE DECISION MADE: 24-AUG-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonata Sonography-Guided Transcervical Fibroid Ablation System
Gynesonics, Inc.                  510(k) NO: K173703(Traditional)
ATTN: Diane  King                 PHONE NO : 650 2163883 
301 Galveston Drive               SE DECISION MADE: 15-AUG-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
The Binding Site Group Ltd        510(k) NO: K173732(Traditional)
ATTN: Christopher  Bradshaw       PHONE NO : 44 0121 4569500 
8 Calthorpe Road Edgbaston        SE DECISION MADE: 23-AUG-18
Birmingham  GB B15 1QT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.                    510(k) NO: K173761(Traditional)
ATTN: Michaela  Mahl              PHONE NO : 510 7483288 
One Penumbra Place                SE DECISION MADE: 17-AUG-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IOLMaster 700
Carl Zeiss Meditec AG             510(k) NO: K173771(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 24-AUG-18
Jena  DE 07445                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
Bayer Medical Care Inc.           510(k) NO: K173773(Traditional)
ATTN: Lisa A Ewing                PHONE NO : 724 8167297 
1 Bayer Drive                     SE DECISION MADE: 17-AUG-18
Indianola PA  15051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smylic Invisible Clear Aligners
Smylio, Inc                       510(k) NO: K173784(Traditional)
ATTN: Ken  Menon                  PHONE NO : 510 8682184 
48890 Milmont Drive               SE DECISION MADE: 23-AUG-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyPlant II Implant System
Hager & Meisinger GmbH            510(k) NO: K173819(Traditional)
ATTN: Adam  Tomczak               PHONE NO : 0049 2131 20120 
Hansemannstrasse 10               SE DECISION MADE: 09-AUG-18
Neuss  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titan Ag 200
Specialty Fibres and Materials Ltd510(k) NO: K173844(Traditional)
ATTN: Lindie  Marx                PHONE NO : 44 02 76708295 
101 Lockhurst Lane                SE DECISION MADE: 09-AUG-18
Coventry  GB Cv6 5sf              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex SwiveLock
Arthrex Inc.                      510(k) NO: K173845(Traditional)
ATTN: David L Rogers              PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 06-AUG-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Model WP-3840 and WP-3040
CNMC Co., Inc.                    510(k) NO: K173848(Traditional)
ATTN: Thomas  Kraus               PHONE NO : 615 3913076 
865 Easthagen Drive               SE DECISION MADE: 07-AUG-18
Nashville TN  37217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Reusable Blood Pressure Cuff
Shenzhen Med-link Electronics Tech510(k) NO: K173869(Traditional)
ATTN: Baihan  Feng                PHONE NO : 0086 755 61568825 833
4th Floor, Building A, Ying TailonSE DECISION MADE: 02-AUG-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK Sphere - Kinematic Alignment
Medacta International SA          510(k) NO: K173890(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 23-AUG-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaPAP Positive Airway Pressure (PAP) Device
Trudell Medical International     510(k) NO: K173918(Traditional)
ATTN: Marianne  Tanton            PHONE NO : 1 519 4557060 
725 Third Street                  SE DECISION MADE: 17-AUG-18
London  CA n5V 5G4                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Temporary Cardiac Pacing Wire
Ethicon, Inc.                     510(k) NO: K173923(Traditional)
ATTN: Joice  Pappan               PHONE NO : 908 2182113 
Route 22 West, P.O. Box 151       SE DECISION MADE: 02-AUG-18
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universal SmartECG
VectraCor, Inc.                   510(k) NO: K173952(Traditional)
ATTN: Andrew  Schreck             PHONE NO : 973 9040444 
785 Totowa Rd. Suite 100          SE DECISION MADE: 28-AUG-18
Totowa NJ  07512                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
Biosense Webster, Inc.            510(k) NO: K173978(Traditional)
ATTN: Phuong  Chau                PHONE NO : 949 9234238 
33 Technology Drive               SE DECISION MADE: 24-AUG-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmCAD-UT Detection 2.2
AmCad BioMed Corporation          510(k) NO: K180006(Traditional)
ATTN: Jack  Yang                  PHONE NO : 886 2 27136227 
FL. 5-2, No. 167, Fu Hsing N. RD. SE DECISION MADE: 31-AUG-18
Taipei  TW 105                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter
Abbott Vascular                   510(k) NO: K180040(Special)
ATTN: Emily  Zhao                 PHONE NO : 408 8453000 
3200 Lakeside Drive               SE DECISION MADE: 24-AUG-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
Shenzhen Vitavitro Bio-tech Co., L510(k) NO: K180073(Traditional)
ATTN: Jenny  Lin                  PHONE NO : 86 755 85235226 
R601, Building B, Hai Ke Xing TechSE DECISION MADE: 29-AUG-18
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINUET LCD, MINUET LCD eco
Unimom Co.                        510(k) NO: K180075(Traditional)
ATTN: Hong  Sang-Hyun             PHONE NO : 82 70 87985577 
110-19 Gajangsaneopseobuk-ro      SE DECISION MADE: 06-AUG-18
Osan-si  KR 18102                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroQ 3.8
Syntermed                         510(k) NO: K180077(Traditional)
ATTN: Kenneth Van Train           PHONE NO : 714 2811290 
245 South Owens Drive             SE DECISION MADE: 16-AUG-18
Anaheim CA  92808                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vicks RapidRead Digital Thermometer
Kaz USA, Inc., A Helen of Troy Com510(k) NO: K180131(Traditional)
ATTN: Matt J. Baun                PHONE NO : 508 4907240 
400 Donald Lynch Boulevard, Suite SE DECISION MADE: 14-AUG-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PL8 Wrist Reconstruction Plate
CITIEFFE S.r.l.                   510(k) NO: K180150(Traditional)
ATTN: Stefano  Pullega            PHONE NO : 39 051 721850 
Via Armaroli, 21                  SE DECISION MADE: 02-AUG-18
Calderara di Reno  IT 40012       510(k) STATEMENT
                                                    

DEVICE: Arm Type Blood Pressure Monitor
Avita Corporation                 510(k) NO: K180155(Traditional)
ATTN: Steven  Jhou                PHONE NO : 886 2 85121568 
9F, No.78, Sec. 1, Kwang-Fu Road. SE DECISION MADE: 03-AUG-18
Taiwan  TW 24158                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EagleRay Long Sheath, 0.088" ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071" ID, 137cm Length, EagleRay Access Catheter, 0.055" ID, 137cm Length, EagleRay Access Catheter, 0.045" ID, 144cm Length, EagleRay Access Catheter, 0.035" ID, 158cm Length
Imperative Care Inc.              510(k) NO: K180169(Traditional)
ATTN: Jake  Wolenberg             PHONE NO : 248 4960198 
1221 Innsbruck Drive              SE DECISION MADE: 08-AUG-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freespira
Palo Alto Health Sciences, Inc.   510(k) NO: K180173(Traditional)
ATTN: Simon  Thomas               PHONE NO : 925 7868409 
12020 113th Ave NE, Building C, SuSE DECISION MADE: 23-AUG-18
Kirkland WA  98034                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw
Orthofix Inc.                     510(k) NO: K180179(Traditional)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 24-AUG-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIO-C REPAIR
Angelus Industria de Produtos Odon510(k) NO: K180185(Traditional)
ATTN: Paulo Sergio Calixto  de OliPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 31-AUG-18
Londrina  BR 86.031-218           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation       510(k) NO: K180186(Traditional)
ATTN: Adam  Heroux                PHONE NO : 781 8940800 
200 Prospect St.                  SE DECISION MADE: 23-AUG-18
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical  Gloves - Tested for Use with Chemotherapy Drugs
Smart Glove Corporation Sdn.Bhd   510(k) NO: K180221((Traditional)
ATTN: Foo Khon Pu                 PHONE NO : 603 32916100 
Lot 6487, Batu 5 3/4, Sementa, JalSE DECISION MADE: 08-AUG-18
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: physiQ Heart Rhythm Module
physiQ Inc.                       510(k) NO: K180234(Traditional)
ATTN: George Allen Hides          PHONE NO : 312 6541010 
300 E. 5th Avenue, Suite 105      SE DECISION MADE: 10-AUG-18
Naperville IL  60563              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VascuEase IC-1200-WH
Bio Compression Systems, Inc.     510(k) NO: K180248(Traditional)
ATTN: Barbara  Whitman            PHONE NO : 201 3406422 
120 W Commercial Ave              SE DECISION MADE: 07-AUG-18
Moonachie NJ  07074               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM 600 Series Endoscope EG-600WR v2
FUJIFILM Corporation              510(k) NO: K180341(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 03-AUG-18
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoWrist Mercury Bipolar Grasper
Intuitive Surgical, Inc.          510(k) NO: K180351(Traditional)
ATTN: Vishal  Kanani              PHONE NO : 408 5232035 
1266 Kifer Road                   SE DECISION MADE: 07-AUG-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CancelleX Porous Titanium Lumbar Interbody Device
Xenco Medical, LLC.               510(k) NO: K180373((Traditional)
ATTN: Gustavo R. Prado            PHONE NO : 858 2021522 
9930 Mesa Rim Road                SE DECISION MADE: 24-AUG-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
BERPU MEDICAL TECHNOLOGY CO., LTD 510(k) NO: K180417(Traditional)
ATTN: Jundong  Tan                PHONE NO : 86 577 86651999 
NO. 14 Xingji Road, Yongxing StreeSE DECISION MADE: 09-AUG-18
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation       510(k) NO: K180428(Traditional)
ATTN: Adam  Heroux                PHONE NO : 781 8940800 
200 Prospect St.                  SE DECISION MADE: 15-AUG-18
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruClear Elite Hysteroscope
Covidien                          510(k) NO: K180496(Traditional)
ATTN: Gail  Yaeker-Daunis         PHONE NO : 203 4926276 
60 Middletown Ave.                SE DECISION MADE: 29-AUG-18
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IGTFusion
IGI Technologies                  510(k) NO: K180522(Traditional)
ATTN: Will  Plishker              PHONE NO : 202 7139571 
387 Technology Dr. #311OD         SE DECISION MADE: 16-AUG-18
College Park MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System – GM Line
JJGC Industria e Comercio de Mater510(k) NO: K180536(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21694000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 30-AUG-18
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deformity Analysis and Correction Software (DACS) and Instrumentation
Arrowhead Medical Device Technolog510(k) NO: K180539(Traditional)
ATTN: Thomas J. Twardzik          PHONE NO : 901 8534366 
328 Poplar View Lane East, Suite 2SE DECISION MADE: 13-AUG-18
Collierville TN  38017            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
Boston Endo Surgical Tech,        510(k) NO: K180542(Traditional)
ATTN: James  Rogers               PHONE NO : 203 3367453 
Division of Lacey Manufacturing CoSE DECISION MADE: 22-AUG-18
Bridgeport CT  06610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
J & J Solutions, Inc. d/b/a/ Corvi510(k) NO: K180574(Traditional)
ATTN: Dana  Schramm               PHONE NO : 651 3983291 
2945 Lone Oak Drive, Suite 150    SE DECISION MADE: 17-AUG-18
Eagan MN  55121                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIQA Dental Implants System
UNIQA DENTAL LTD                  510(k) NO: K180598((Traditional)
ATTN: Dima  Goberman              PHONE NO : 972 77 7827367 
26 Tom Lantos blvd, Alon Center   SE DECISION MADE: 08-AUG-18
Netanya  IL 4276001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geister retractor for neuro - and spine surgery
Geister Medizintechnik GmbH       510(k) NO: K180610(Traditional)
ATTN: Christian  Grotzinger       PHONE NO : 49 7461 96624109 
Forhenstrasse 2                   SE DECISION MADE: 29-AUG-18
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bongo
InnoMed Healthscience, Inc.       510(k) NO: K180619((Traditional)
ATTN: Javier  Collazo             PHONE NO : 954 7739656 
1701 W. Hillsboro Blvd., Suite 303SE DECISION MADE: 16-AUG-18
Deerfield Beach FL  33442         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Silver Post Operative Dressing
Advanced Medical Solutions Ltd.   510(k) NO: K180634(Traditional)
ATTN: Rose  Guang                 PHONE NO : 44 1606 863500 
Premier Park, 33 Road One, WinsforSE DECISION MADE: 07-AUG-18
Winsford  GB CW7 3RT              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Hartalega Sdn Bhd                 510(k) NO: K180644(Traditional)
ATTN: Mr. Kuan Kam Hon            PHONE NO : 603 62771733 
C-G-9, Jalan Dataran Sd 1 Dataran SE DECISION MADE: 10-AUG-18
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K180647(Traditional)
ATTN: Anna  Kuperberg             PHONE NO : 1 315 2073494 
Yigal Alon 92                     SE DECISION MADE: 01-AUG-18
Tel-Aviv  IL 6789138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K180698(Traditional)
ATTN: Lavinia  Tompkins           PHONE NO : 44 1482 225181 
101 Hessle Road                   SE DECISION MADE: 21-AUG-18
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITA YZ ST and VITA YZ XT
VITA Zahnfabrik H.Rauter GmbH Co. 510(k) NO: K180703(Abbreviated)
ATTN: Bernd  Walker               PHONE NO : 49 776 1562361 
Spitelgasse 3                     SE DECISION MADE: 01-AUG-18
Bad Sackingen  DE D-79713         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie               510(k) NO: K180734((Traditional)
ATTN: Maylin  Truesdell           PHONE NO : 978 4822365 
300 Brickstone Square, Suite 203  SE DECISION MADE: 08-AUG-18
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound Scanner System bk2300
BK Medical ApS                    510(k) NO: K180737(Traditional)
ATTN: Susana  Mogensen            PHONE NO : 45 44 528105 
Mileparken 34                     SE DECISION MADE: 01-AUG-18
Herlev  DK 2730                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECULOK™ Suture Anchor
U & I Corporation                 510(k) NO: K180759(Traditional)
ATTN: Bo-Ram  Kang                PHONE NO : 82 31 8606839 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 09-AUG-18
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
Church & Dwight Co., Inc          510(k) NO: K180764(Traditional)
ATTN: Joelle  Reinson             PHONE NO : 609 8061671 
500 Charles Ewing Blvd.           SE DECISION MADE: 01-AUG-18
Ewing NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Propeller Sensor for Neohaler
Reciprocal Labs Corporation       510(k) NO: K180770(Traditional)
ATTN: David  Hubanks              PHONE NO : 608 2510470 
634 West Main St.                 SE DECISION MADE: 01-AUG-18
Madison WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Watch-PAT300
Itamar Medical, Ltd.              510(k) NO: K180775(Traditional)
ATTN: Koby  Sheffy                PHONE NO : 972 4 6177000 
9 Halamish St.                    SE DECISION MADE: 17-AUG-18
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Expandable Interbody System
K2M, Inc.                         510(k) NO: K180777(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 03-AUG-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meta P&Bond
META BIOMED, CO., LTD.            510(k) NO: K180802(Traditional)
ATTN: Suk Song Oh                 PHONE NO : 82 43 2308959 
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 29-AUG-18
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure EP
BioSig Technologies               510(k) NO: K180805((Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
12424 Wilshire Blvd, Suite 745    SE DECISION MADE: 08-AUG-18
Los Angeles CA  90025             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLink® M3™ Stand-Alone Anterior Lumbar System
CoreLink, LLC                     510(k) NO: K180814(Traditional)
ATTN: Steve  Mounts               PHONE NO : 888 3497808 
7911 Forsyth Blvd., Suite 200     SE DECISION MADE: 10-AUG-18
St. Louis MO  63105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fluent Fluid Management System
Hologic, Inc.                     510(k) NO: K180825(Traditional)
ATTN: Christine  Cameron          PHONE NO : 508 2638654 
250 Campus Drive                  SE DECISION MADE: 03-AUG-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altrix Precision Temperature Management System
Stryker Medical                   510(k) NO: K180834(Traditional)
ATTN: Brian  Orwat                PHONE NO : 269 3292100 
3800 East Centre Avenue           SE DECISION MADE: 10-AUG-18
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: re.t.a Reuseable Tampon Applicator
Thinx, Inc.                       510(k) NO: K180850(Traditional)
ATTN: Kerrie  Timmons             PHONE NO : 1 347 2109607 
601 W 26th Street, Suite 515      SE DECISION MADE: 20-AUG-18
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EP Granules™ BVF
Elute, Inc.                       510(k) NO: K180853((Traditional)
ATTN: Kirk  Andriano              PHONE NO : 781 2908323 
417 Wakara Way Suite 3510         SE DECISION MADE: 06-AUG-18
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareSens S Fit Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K180866(Traditional)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100453 
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 31-AUG-18
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LYFT
Uplevity, Inc.                    510(k) NO: K180888(Traditional)
ATTN: Thomas  Kraft               PHONE NO : 1 217 7623148 
40 Marshfield Rd                  SE DECISION MADE: 30-AUG-18
Niantic CT  06357                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HORIZON TMS Therapy System
Magstim Company Ltd.              510(k) NO: K180907(Traditional)
ATTN: Tom  Campbell               PHONE NO : 440 1994 240798 
Spring Gardens                    SE DECISION MADE: 03-AUG-18
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioWaveGO
Biowave Corporation               510(k) NO: K180943(Traditional)
ATTN: Bradford  Siff              PHONE NO : 203 6357175 
8 Knight Street, Suite 201        SE DECISION MADE: 17-AUG-18
Norwalk CT  06851                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: exGraft, exGraft Carbon ePTFE Vascular Grafts
PECA Labs                         510(k) NO: K180957(Traditional)
ATTN: Doug  Bernstein             PHONE NO : 877 8422873 
4424 Penn Ave, Suite 201          SE DECISION MADE: 21-AUG-18
Pittsburgh PA  15224              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions
KLS-Martin L.P.                   510(k) NO: K180962(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial ParkwSE DECISION MADE: 13-AUG-18
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CBit Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., L510(k) NO: K180974(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 0086 510 85311707 
No.228, Changjiang East Road, BlocSE DECISION MADE: 17-AUG-18
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TirboLOX-L Lumbar IBFD
Captiva Spine, Inc.               510(k) NO: K180990(Traditional)
ATTN: Jackie  Ferro               PHONE NO : 877 7725571 
967 N. Alternate A1A, Suite 1     SE DECISION MADE: 13-AUG-18
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cianna Medical SAVI Scout Reflector and SAVI Scout System
Cianna Medical, Inc.              510(k) NO: K181007(Traditional)
ATTN: Gary  Mocnik                PHONE NO : 949 3600059 134
6 Journey, Suite 125              SE DECISION MADE: 02-AUG-18
Aliso Viejo CA  92656             510(k) STATEMENT
                                                    

DEVICE: APTUS CMC-I Fusion Plate System
Medartis AG                       510(k) NO: K181009(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 24-AUG-18
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fever Scout
VivaLnk Inc.                      510(k) NO: K181013(Traditional)
ATTN: Christine  Kuo              PHONE NO : 1 408 8682898 
4655 Old Ironsides Drive, Suite 39SE DECISION MADE: 21-AUG-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytosponge Cell Collection Device
Covidien llc                      510(k) NO: K181020(Traditional)
ATTN: Rachel  Silva               PHONE NO : 408 3287359 
15 Hampshire Street               SE DECISION MADE: 16-AUG-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS Small Fragment Plating System Lite
Advanced Orthopaedic Solutions, In510(k) NO: K181035(Traditional)
ATTN: Alex  Bhaskarla             PHONE NO : 310 5339966 
3203 Kashiwa Street               SE DECISION MADE: 24-AUG-18
Torrance CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System Cranial Application
7D Surgical Inc.                  510(k) NO: K181041((Traditional)
ATTN: Daniel  Ziskind             PHONE NO : 647 4840079 
60 Scarsdale Road, Unit 118       SE DECISION MADE: 08-AUG-18
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire 2 and Solitaire Platinum Revascularization Device
Medtronic Neurovascular           510(k) NO: K181060(Traditional)
ATTN: Amnon  Talmor               PHONE NO : 949 2979270 
9775 Toledo Way                   SE DECISION MADE: 24-AUG-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Insulin Pen Needle
Zhejiang Kindley medical devices C510(k) NO: K181069(Traditional)
ATTN: Yong  Zhang                 PHONE NO : 86 577 86960616 
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 28-AUG-18
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simple Science Antimicrobial Facial and Eyelid Cleanser
Simple Science LLC                510(k) NO: K181074(Traditional)
ATTN: Eoin  Croke                 PHONE NO : 612 3674540 207
5555 W 78th St. STE M             SE DECISION MADE: 17-AUG-18
Edina MN  55439                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polydioxanone Surgical Scaffold
Surgical Innovation Associates, In510(k) NO: K181094(Traditional)
ATTN: Alexei  Mlodinow            PHONE NO : 626 3724884 
965 West Chicago Ave              SE DECISION MADE: 02-AUG-18
Chicago IL  60642                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
Shenzhen Combei Technology CO., LT510(k) NO: K181104(Traditional)
ATTN: Kevin  Fong                 PHONE NO : 86 0755 29588956 
11-5B No.105, Huanguan South Road,SE DECISION MADE: 29-AUG-18
Guanlan, Shenzhen  CN 518110      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Hebei Titans Hongsen Medical Techn510(k) NO: K181130(Traditional)
ATTN: Shaozhang  Nan              PHONE NO : 86 319 7295820 
Eastern Industrial Zone           SE DECISION MADE: 10-AUG-18
Nangong  CN 051800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASK System
L and K Biomed Corporation Limited510(k) NO: K181146(Traditional)
ATTN: Semi  Jang                  PHONE NO : 82 2 67171985 
18f, 159-1, Mokdongseo-ro         SE DECISION MADE: 03-AUG-18
Yangcheon-gu  KR 07997            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
Zenith Technical Innovations      510(k) NO: K181149(Traditional)
ATTN: Greg  Binversie             PHONE NO : 847 6727481 
1396 St. Paul Ave                 SE DECISION MADE: 03-AUG-18
Gurnee IL  60031                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
Ethicon Inc                       510(k) NO: K181151(Traditional)
ATTN: Debbie  Fazen               PHONE NO : 908 2182595 
Route 22 West                     SE DECISION MADE: 10-AUG-18
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DYNACORD Suture
Medos International SARL          510(k) NO: K181182(Traditional)
ATTN: Tatyana  Korsunsky          PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 02-AUG-18
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Change Healthcare Enterprise Viewer
Change Healthcare Canada Company  510(k) NO: K181185(Traditional)
ATTN: Nadia  Marchant             PHONE NO : 604 2795422 
10711 Cambie Road                 SE DECISION MADE: 29-AUG-18
Richmond  CA V6X3G5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHMB Foam Wound Dressing
Advanced Medical Solutions Ltd.   510(k) NO: K181197(Traditional)
ATTN: Rose  Guang                 PHONE NO : 44 1606 863500 
Premier Park, 33 Road One, WinsforSE DECISION MADE: 03-AUG-18
Winsford  GB CW7 3RT              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GentleCath Glide Intermittent Urinary Catheter
ConvaTec Limited                  510(k) NO: K181206(Traditional)
ATTN: Elinor  Jones               PHONE NO : 44 0 1244 854176
GDC, First Avenue, Deepside IndustSE DECISION MADE: 16-AUG-18
Deeside  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VesoFlow Lite DVT Compression Device
Caremed Supply, Inc.              510(k) NO: K181217(Traditional)
ATTN: Tsung-Hsuan  Liu            PHONE NO : 886 2 29179808 
7F., No. 2, Lane 235, Baoqiao Rd.,SE DECISION MADE: 05-AUG-18
New Taipei City  TW 23145         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignRT Plus
Vision RT Ltd                     510(k) NO: K181218(Traditional)
ATTN: Chris  Hannan               PHONE NO : 44 7591 020326 
Dove House, Arcadia Avenue        SE DECISION MADE: 07-AUG-18
London  GB n3 2ju                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiPillows EPAP Mask
Cpapnea Medical Supply            510(k) NO: K181219(Traditional)
ATTN: Sal T. Hakim                PHONE NO : 1 602 9440847 
10443 N Cave Creek Rd, Suite 110  SE DECISION MADE: 03-AUG-18
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTAPORE
Baxter Healthcare Corporation     510(k) NO: K181225(Traditional)
ATTN: Caitlin  Ziebell            PHONE NO : 224 2702097 
32650 N. Wilson Road              SE DECISION MADE: 31-AUG-18
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IlluminOss Bone Stabilization System
IlluminOss Medical, Inc.          510(k) NO: K181228(Traditional)
ATTN: Robert  Rabiner             PHONE NO : 401 7140008 
993 Waterman Avenue               SE DECISION MADE: 31-AUG-18
East Providence RI  02914         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Self-adhesive Electrode
Dong Guan Ou Kang Electronics CO.,510(k) NO: K181234(Traditional)
ATTN: Nianjun  Liu                PHONE NO : 86 0769 82686009 
3rd Floor, Xiqunli building, ShipaSE DECISION MADE: 07-AUG-18
Dongguan  CN 523407               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glidesheath Slender Tibial Pedal Kit
Terumo Medical Corporation        510(k) NO: K181237(Traditional)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd.                  SE DECISION MADE: 03-AUG-18
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
PJM Worldwide, LLC d/b/a Phoenix M510(k) NO: K181253(Traditional)
ATTN: Ira  Nusbaum                PHONE NO : 305 4772515 
1499 NW 79th Avenue               SE DECISION MADE: 10-AUG-18
Miami FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PlasmaBlade X 3.0S, PlasmaBlade X 4.0
Medtronic Advanced Energy         510(k) NO: K181257(Traditional)
ATTN: Heather  Valley             PHONE NO : 603 2945447 
180 International Drive           SE DECISION MADE: 02-AUG-18
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpineJack Expansion Kit
Vexim SA                          510(k) NO: K181262(Traditional)
ATTN: Vincent  Gardes             PHONE NO : 011 335 61488663 
8 Rue Vidailhan                   SE DECISION MADE: 30-AUG-18
Balma  FR 31130                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
Cepheid                           510(k) NO: K181289(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 15-AUG-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine AIS-C Cervical Stand-Alone System
Genesys Spine                     510(k) NO: K181295(Traditional)
ATTN: Benjamin V. Keller          PHONE NO : 512 3817093 
1250 Capital of Texas Highway SoutSE DECISION MADE: 29-AUG-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Actifuse Flow
Baxter Healthcare Corporation     510(k) NO: K181306(Special)
ATTN: Daniel  Davis               PHONE NO : 224 2702097 
32650 N Wilson Rd                 SE DECISION MADE: 17-AUG-18
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperGrow 272, Ultimate 272
Super Grow Lasers                 510(k) NO: K181308(Traditional)
ATTN: Jeffrey  Stanifer           PHONE NO : 1 713 5516320 
1903 Commonwealth Street #16      SE DECISION MADE: 15-AUG-18
Houston TX  77006                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GrandioSO x-tra
VOCO GmbH                         510(k) NO: K181312(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 22-AUG-18
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: BenQ Diagnostic Ultrasound System
Qisda Corporation                 510(k) NO: K181313(Traditional)
ATTN: Johnson  Sheu               PHONE NO : 886 3359 5000 3822
No.157, Shanying Rd., Gueishan DisSE DECISION MADE: 27-AUG-18
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONIS-PACS
DigitalCore Co., Ltd              510(k) NO: K181318(Traditional)
ATTN: Lemoigne  Cedric            PHONE NO : 81 357271064 
Setagaya-Ku Kinuta 5-8-31 Ginga M2SE DECISION MADE: 13-AUG-18
Tokyo  JP 1570073                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlas Gold PTA Dilatation Catheter
C. R. Bard, Inc.                  510(k) NO: K181323(Traditional)
ATTN: Aaron  Conovaloff           PHONE NO : 480 3506012 
1625 West 3rd Street              SE DECISION MADE: 03-AUG-18
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Herpes-1 IgG
Biokit, S.A.                      510(k) NO: K181333(Traditional)
ATTN: Joan  Guixer                PHONE NO : 34 938 609000 
Can Male S/N                      SE DECISION MADE: 23-AUG-18
Llica d’Amunt  ES 08186           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Herpes-2 IgG
Biokit, S.A.                      510(k) NO: K181334(Traditional)
ATTN: Joan  Guixe                 PHONE NO : 34 938 609000 
Can Male, S/N                     SE DECISION MADE: 23-AUG-18
Llica d'Amunt  ES 08186           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CystoSure Plus Catheter
Emmy Medical, LLC.                510(k) NO: K181346(Traditional)
ATTN: Ronald  Adams               PHONE NO : 755 8007300 
18 Hillside Drive                 SE DECISION MADE: 06-AUG-18
Holliston MA  01746               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aries® Lumbar Interbodies
Osseus Fusion Systems, LLC        510(k) NO: K181347(Traditional)
ATTN: Robert  Pace                PHONE NO : 214 3950100 
2703 Mockingbird Lane, Suite 102  SE DECISION MADE: 15-AUG-18
Dallas TX  75235                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InterActive SMARTBase Abutments
Implant Direct Sybron Manufacturin510(k) NO: K181359(Traditional)
ATTN: Reina  Choi                 PHONE NO : 818 4443306 
3050 East Hillcrest Drive         SE DECISION MADE: 15-AUG-18
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tenex Health TX System
Tenex Health, Inc.                510(k) NO: K181367(Traditional)
ATTN: David  Vancelette           PHONE NO : 949 4547500 
26902 Vista Terrace               SE DECISION MADE: 28-AUG-18
Lake Forest, CA  92630            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: H. PYLORI QUIK CHEK
TECHLAB, Inc.                     510(k) NO: K181379(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive Corporate ResearcSE DECISION MADE: 21-AUG-18
Blacksburg VA  24060-6358         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Brigade Lateral System
NuVasive, Incorporated            510(k) NO: K181386(Traditional)
ATTN: Jessica  Silverman          PHONE NO : 858 9093302 
7475 Lusk Blvd.                   SE DECISION MADE: 24-AUG-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: H. PYLORI CHEK™
TECHLAB, Inc.                     510(k) NO: K181400(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive Corporate ResearcSE DECISION MADE: 21-AUG-18
Blacksburg VA  24060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Artis zee/zeego & Artis Q/Q.zen
Siemens Medical Solution USA, Inc.510(k) NO: K181407(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 15-AUG-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Classic Hybrid Personal Lubricant
United Consortium                 510(k) NO: K181408(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 27-AUG-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uCT 530, uCT 550
Shanghai United Imaging Healthcare510(k) NO: K181414(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 2167 0768886776 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 14-AUG-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS® Proximal Humerus System
Medartis AG                       510(k) NO: K181425(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 05-AUG-18
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
LENSAR, Inc.                      510(k) NO: K181430(Traditional)
ATTN: Keith  Peck                 PHONE NO : 888 5756412 
2800 Discovery Drive, Suite 100   SE DECISION MADE: 09-AUG-18
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProVectra 3D Prime with VistaSoft
Durr Dental SE                    510(k) NO: K181432(Traditional)
ATTN: Oliver  Lange               PHONE NO : 490 7142 705190 
Hopfigheimer Strasse 17           SE DECISION MADE: 02-AUG-18
Bietigheim-Bissingen  DE D-74321  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATEC Cervical Spacer System
Alphatec Spine, Inc.              510(k) NO: K181435(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 1 760 4946740 
5818 El Camino Real               SE DECISION MADE: 21-AUG-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpyGlass DS and DS II Direct Visualization System
Boston Scientific Corporation     510(k) NO: K181439(Special)
ATTN: Carter  Navarro             PHONE NO : 508 6834793 
100 Boston Scientific  Way        SE DECISION MADE: 23-AUG-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
DiaSorin Inc.                     510(k) NO: K181464(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Ave.            SE DECISION MADE: 31-AUG-18
Stillwater MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACCUFUSE Cervical System
Absolute Advantage Medical, LLC   510(k) NO: K181471(Traditional)
ATTN: J.D.  Webb                  PHONE NO : 
2731 Millbrook Road               SE DECISION MADE: 29-AUG-18
Fayetteville NC  78681            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DENV Detect NS1 ELISA
InBios International, Inc.        510(k) NO: K181473(Traditional)
ATTN: Estela  Raychaudhuri        PHONE NO : 206 3445821 
307 Westlake Ave N, Suite 300     SE DECISION MADE: 27-AUG-18
Seattle WA  98109                 510(k) STATEMENT
                                                    

DEVICE: Ingenia Ambition S and Ingenia Ambition X
Philips Medical Systems Nederland 510(k) NO: K181479(Abbreviated)
ATTN: Jan Van de Kerkhof          PHONE NO : 31 613 300542 
Veenpluis 4-6                     SE DECISION MADE: 03-AUG-18
Best  NL 5684pc                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MMD Tip
Strata Skin Sciences, Inc.        510(k) NO: K181480(Traditional)
ATTN: Shmuel  Gov                 PHONE NO : 215 6193200 
100 Lakeside Dr. Suite 100        SE DECISION MADE: 01-AUG-18
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: myTAP2
Airway Management, Inc.           510(k) NO: K181482(Traditional)
ATTN: Eric  Jarrett               PHONE NO : 866 2647667 354
3418 Midcourt Road                SE DECISION MADE: 31-AUG-18
Carrollton TX  75006              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tranquil Interbody System
Nexus Spine, LLC                  510(k) NO: K181483(Traditional)
ATTN: Jared  Crocker              PHONE NO : 801 7028342 
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 27-AUG-18
Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEKA Motus AY
Elen Electronic Engineering Spa   510(k) NO: K181486(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8826807 
Via Baldanzese, 17                SE DECISION MADE: 30-AUG-18
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRILLIANT Crios
Coltene/Whaledent AG              510(k) NO: K181500(Traditional)
ATTN: Daniel  Meier               PHONE NO : 41 71 7575852 
Feldwiesenstrasse 20              SE DECISION MADE: 15-AUG-18
Altstaetten  CH 9450              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zio AT ECG Monitoring System, ZEUS System
iRhythm Technologies, Inc.        510(k) NO: K181502(Traditional)
ATTN: Rich  Laguna                PHONE NO : 415 6325700 
650 Townsend Street, Suite 500    SE DECISION MADE: 29-AUG-18
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex PushLock Tenodesis Anchor
Arthrex Inc.                      510(k) NO: K181513(Special)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 30-AUG-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Wrist Fracture Plating System
Smith & Nephew, Inc.              510(k) NO: K181533(Traditional)
ATTN: Bryan  Cowell               PHONE NO : 978 7491093 
1450 Brooks Road                  SE DECISION MADE: 09-AUG-18
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cure™ OPEL-C Plate System
Meditech Spine, LLC               510(k) NO: K181543(Traditional)
ATTN: Bruce  Dunaway              PHONE NO : 678 9745287 
1447 Peachtree St NE Suite 440    SE DECISION MADE: 31-AUG-18
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchor Bolt (as an accessory to Depth Electrodes)
Ad-Tech Medical Instrument Corpora510(k) NO: K181544(Traditional)
ATTN: Lisa  Theama                PHONE NO : 262 6341555 
400 West Oakwood Road             SE DECISION MADE: 09-AUG-18
Oak Creek WI  53154               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)
Curiteva, LLC                     510(k) NO: K181549(Traditional)
ATTN: Eric  Linder                PHONE NO : 256 2131057 
25127 Will McComb Drive Suite 100 SE DECISION MADE: 03-AUG-18
Tanner AL  35671                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFINITY Total Ankle System
Wright Medical Technology, Inc.   510(k) NO: K181557(Traditional)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 09-AUG-18
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curiteva Anterior Cervical Plate System
Curiteva, LLC                     510(k) NO: K181562(Traditional)
ATTN: Eric  Linder                PHONE NO : 256 2131057 
25127 Will McComb Drive, Suite 100SE DECISION MADE: 02-AUG-18
Tanner AL  35671                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DemeTECH DemeDIOX absorbable surgical suture
Demetech Corporation              510(k) NO: K181582(Special)
ATTN: Linda  Hernandez            PHONE NO : 305 8241048 
14175 NW 60th Ave                 SE DECISION MADE: 27-AUG-18
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Redi-Spine
Innovative Surgical Designs, Inc. 510(k) NO: K181584(Traditional)
ATTN: Jon  Rinehart               PHONE NO : 217 8368522 
3903 S. Walnut St.                SE DECISION MADE: 10-AUG-18
Bloomington IN  47401             510(k) STATEMENT
                                                    

DEVICE: RAIN Sheath Transradial
Cordis Corporation                510(k) NO: K181592(Traditional)
ATTN: Ankita  Phophalia           PHONE NO : 408 2733228 
1820 McCarthy Boulevard           SE DECISION MADE: 15-AUG-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Galan 3T, MRT-3020/A7, V5.0
Canon Medical Systems Corporation 510(k) NO: K181593(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 13-AUG-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce GX560, GX560-AR
EIZO Corporation                  510(k) NO: K181609(Abbreviated)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 762 742468 
153 Shimokashiwano                SE DECISION MADE: 24-AUG-18
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
Bausch & Lomb Incorporated        510(k) NO: K181627(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 585 3386045 
1400 North Goodman Street         SE DECISION MADE: 10-AUG-18
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK Sphere CR Tibial Inserts
Medacta International SA          510(k) NO: K181635(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 23-AUG-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart One
MIR Medical International Research510(k) NO: K181666(Third Party - Traditional)
ATTN: Gerda  Van Houts            PHONE NO : 39 06 22754777 
Via del Maggiolino, 125           SE DECISION MADE: 01-AUG-18
Roma  IT 00155                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Mini Ridge Filter and auxiliary functions for PROBEAT-V
Hitachi Ltd. Healthcare Hitachi Wo510(k) NO: K181676(Traditional)
ATTN: Tomoyuki  Seino             PHONE NO : 81 294 555232 
3-1-1, Saiwai-Cho                 SE DECISION MADE: 15-AUG-18
Hitachi  JP 317-8511              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kodiak Spinal Fixation System
Alphatec Spine, Inc.              510(k) NO: K181677(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 760 4946740 
5818 El Camino Real               SE DECISION MADE: 09-AUG-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICONN Answer II Suture Anchor
ICONN Orthopedics, LLC            510(k) NO: K181680(Traditional)
ATTN: Whitt  Israel               PHONE NO : 205 9132068 
400 Union Hill Drive, Suite 150   SE DECISION MADE: 09-AUG-18
Birmingham AL  35209              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX CT/GC/TV 20-Day QC Panel
Microbiologics, Inc.              510(k) NO: K181683(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 28-AUG-18
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
Microbiologics, Inc.              510(k) NO: K181711(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 15-AUG-18
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultraxx Nephrostomy Balloon Catheter Set
Cook Incorporated                 510(k) NO: K181713(Traditional)
ATTN: Minjin  Choi                PHONE NO : 812 3353575 104901
750 Daniels Way                   SE DECISION MADE: 17-AUG-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc.           510(k) NO: K181740(Traditional)
ATTN: Ewald  Riechert             PHONE NO : 925 5682977 
4410 Rosewood Drive               SE DECISION MADE: 29-AUG-18
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperCable® Iso-Elastic™ Cerclage System
Kinamed, Incorporated             510(k) NO: K181749(Special)
ATTN: Heather  Neely              PHONE NO : 805 8861069 
820 Flynn Road                    SE DECISION MADE: 01-AUG-18
Camarillo CA  93010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Select
Siemens Medical Solutions USA, Inc510(k) NO: K181767(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 17-AUG-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Assure Tech (Hangzhou) Co., Ltd.  510(k) NO: K181768(Traditional)
ATTN: Shisheng  Ling              PHONE NO : 86 571 88868960 
2nd-5th Floor, Building 4, No. 141SE DECISION MADE: 20-AUG-18
Hangzhou  CN 310011               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
Ceterix Orthopaedics, Inc.        510(k) NO: K181772(Special)
ATTN: Tarhan  Kayihan             PHONE NO : 650 3963478 
6500 Kaiser Drive, Suite 120      SE DECISION MADE: 01-AUG-18
Fremont CA  94555                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIMPLYSTRONG, SIMPLYEZEE
Genicon, Inc                      510(k) NO: K181791(Traditional)
ATTN: Katlyn  Kachman             PHONE NO : 407 6574851 614
6869 Stapoint Court Suite 114     SE DECISION MADE: 21-AUG-18
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duo™ Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K181792(Special)
ATTN: Karen  Roche                PHONE NO : 651 2568500 
7800 Third Street N., Suite 600   SE DECISION MADE: 14-AUG-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
Alcon Laboratories, Inc.          510(k) NO: K181796(Special)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 03-AUG-18
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips CT Big Bore Sliding Gantry Configuration
Phillips Medical Systems (Clevelan510(k) NO: K181797(Special)
ATTN: Michael  Chilbert           PHONE NO : 440 8694576 
595 Miner Road                    SE DECISION MADE: 03-AUG-18
Cleveland OH  44143               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ResCUBE™ Ligament Fixation System
Cousin Biotech S.A.S.             510(k) NO: K181799(Traditional)
ATTN: Mathilde  Collet            PHONE NO : 011 333 20144130 
8 Rue De L'abbe Bonpain           SE DECISION MADE: 29-AUG-18
Wervicq-Sud  FR 59117             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alphenix, INFX-8000C/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K181804(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 02-AUG-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRYPHON® Anchors with DYNACORD™ Suture
Medos International SARL          510(k) NO: K181809(Special)
ATTN: Tatyana  Korsunsky          PHONE NO : 508 8283122 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 03-AUG-18
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
Scientia Vascular LLC             510(k) NO: K181828(Special)
ATTN: David  Sabodski             PHONE NO : 888 3859016 
3487 West 2100 South Suite 100    SE DECISION MADE: 07-AUG-18
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Azurion R2.0
Philips Medical Systems Nederland 510(k) NO: K181830(Special)
ATTN: Owen  Callaghan             PHONE NO : 31 621 394159 
Veenpluis 4-6                     SE DECISION MADE: 02-AUG-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
Cordis, a Cardinal Health Company 510(k) NO: K181836(Special)
ATTN: Vidya  Venkataeaghavan      PHONE NO : 408 2733451 
1820 McCarthy Boulevard           SE DECISION MADE: 08-AUG-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iStim S2 OTC Pain Relief TENS
Everyway Medical Instruments CO., 510(k) NO: K181849(Special)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3 Fl., No. 5, Lane 155, Sec.3 BeisSE DECISION MADE: 10-AUG-18
New Taipei City  TW 22203         510(k) STATEMENT
                                                    

DEVICE: Alere BinaxNOW Influenza A & B Card 2, Alere Reader
Alere Scarborough, Inc.           510(k) NO: K181853(Special)
ATTN: Angela  Drysdale            PHONE NO : 207 4151393 
10 Southgate Road                 SE DECISION MADE: 08-AUG-18
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MotoCLIP/HiMAX Step Staple Implant System
CrossRoads Extremity Systems, LLC 510(k) NO: K181866(Special)
ATTN: Chad  Hollis                PHONE NO : 901 2218406 
6055 Primacy Pkwy, Suite 140      SE DECISION MADE: 09-AUG-18
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable X-ray System (Model: MiniX-V, Mini X-S)
Digimed Co., LTD.                 510(k) NO: K181891(Traditional)
ATTN: Youngbae  Kwon              PHONE NO : 82 226 241551 
309-311, 318-ho, 145, Gasan digitaSE DECISION MADE: 10-AUG-18
Seoul  KR 08506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luminelle DTx Hysteroscopy System
UVision360 Inc.                   510(k) NO: K181909(Third Party - Traditional)
ATTN: Allison London Brown        PHONE NO : 888 8559360 
4441-106 Six Forks Road, #179     SE DECISION MADE: 16-AUG-18
Raleigh NC  27609                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Quantum Workstation 12.1"
Spectrum Medical Ltd              510(k) NO: K181923(Special)
ATTN: Colleen  Powell             PHONE NO : 440 1242 650120 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 17-AUG-18
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
W. L. Gore & Associates, Inc.     510(k) NO: K181940(Special)
ATTN: Michael J. Titus            PHONE NO : 410 5068316 
301 Airport Road                  SE DECISION MADE: 17-AUG-18
Elkton MD  21922                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSCAR (OSCAR Prime, OSCAR Classic)
Genoray Co., Ltd.                 510(k) NO: K181943(Traditional)
ATTN: Jeff  Hwang                 PHONE NO : 82 316273953 
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 17-AUG-18
Seongnam  KR 13230                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
Thermo Fisher Scientific          510(k) NO: K181946(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322
1 Thermo Fisher Way               SE DECISION MADE: 08-AUG-18
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: autoLog IQ Autotransfusion System
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K181954(Special)
ATTN: Sue  Fidler                 PHONE NO : 763 5149839 
7611 Northland Drive              SE DECISION MADE: 22-AUG-18
Brooklyn Park MN  55428           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CubeVue
CurveBeam, LLC                    510(k) NO: K181962(Third Party - Traditional)
ATTN: Stuti  Singh                PHONE NO : 267 4838081 
175 Titus Ave Suite 300           SE DECISION MADE: 07-AUG-18
Warrington PA  18976              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SmartPerfusion
Philips Medical Systems Nederlands510(k) NO: K181966(Special)
ATTN: Chandrika  Srinivasan       PHONE NO : 91 974 0900311 
Veenpluis 4-6                     SE DECISION MADE: 17-AUG-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Safecare Biotech(Hangzhou)Co.,Ltd.510(k) NO: K181968(Traditional)
ATTN: Alex  Qiu                   PHONE NO : 86 571 89712897 
Building 2/203 No.18 Haishu Rd. CaSE DECISION MADE: 20-AUG-18
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc.                   510(k) NO: K181973(Special)
ATTN: Brenna  Loufek              PHONE NO : 763 5262365 
8200 Coral Sea Street NE          SE DECISION MADE: 21-AUG-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyoSure XL Tissue Removal Device for Fluent
Hologic, Inc                      510(k) NO: K181974(Special)
ATTN: Rachelle D. Fitzgerald      PHONE NO : 508 2638631 
250 Campus Drive                  SE DECISION MADE: 23-AUG-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiScope Digital Endoscope System
OTU Medical Inc.                  510(k) NO: K181977(Third Party - Traditional)
ATTN: Doris  Dong                 PHONE NO : 86 21 31261348 
2231A Fortune Drive               SE DECISION MADE: 14-AUG-18
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
Medyssey USA, Inc.                510(k) NO: K181978(Special)
ATTN: Shawn  Kim                  PHONE NO : 847 4270200 
1550 E. Higgins Road, Suite 123   SE DECISION MADE: 13-AUG-18
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIDAScope and Introducer Kit, and MIDASystem
IntraVu, Inc.                     510(k) NO: K181982(Third Party - Traditional)
ATTN: Plamena  Entcheva-Dimitrov  PHONE NO : 650 5332253 
610 Price Avenue                  SE DECISION MADE: 21-AUG-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PreXion 3D Excelsior
PreXion Corporation               510(k) NO: K181983(Special)
ATTN: Katsumi  Hayashi            PHONE NO : 81 5297 7551 
1-14-1 Kandasuda-cho              SE DECISION MADE: 17-AUG-18
Chiyoda-ku  JP 101-0041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA    510(k) NO: K181997(Special)
ATTN: Sonia  Callegaro            PHONE NO : 41 22 9944700 
Ch de la Vuarpilliere             SE DECISION MADE: 30-AUG-18
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Endoscopic Ultrasound System
PENTAX of America, Inc.           510(k) NO: K182004(Special)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 21-AUG-18
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dissecting Balloon System
Applied Medical Resources Corp.   510(k) NO: K182024(Traditional)
ATTN: Corinne  Yestrepsky         PHONE NO : 949 7138176 
22872 Avenida Empresa             SE DECISION MADE: 30-AUG-18
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natrelle 133S Tissue Expander
Allergan                          510(k) NO: K182054(Special)
ATTN: Melissa  Pathmajeyan        PHONE NO : 714 2465919 
2525 Dupont Drive                 SE DECISION MADE: 29-AUG-18
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyMax BT Self-Monitoring Blood Glucose System
EPS Bio Technology Corp.          510(k) NO: K182057(Special)
ATTN: Cynthia  Hung               PHONE NO : 886 3 6686868 
No. 8, R&D RD III Hsinchu Science SE DECISION MADE: 24-AUG-18
Hsinchu  TW 30077                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PleuraFlow System with FlowGlide Extra Drainage Length
ClearFlow, Inc.                   510(k) NO: K182067(Special)
ATTN: Dov  Gal                    PHONE NO : 714 9165014 
1630 S. Sunkist St. Suite E       SE DECISION MADE: 14-AUG-18
Anaheim CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CarriGen PF
ETEX Corporation                  510(k) NO: K182107(Special)
ATTN: Stacy  Hutchens             PHONE NO : 617 5777270 
38 Sidney Street, 3rd FLoor       SE DECISION MADE: 31-AUG-18
Cambridge MA  02139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182119(Special)
ATTN: Ankit K. Shah               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 29-AUG-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    


               TOTAL 510(k)s THIS PERIOD   249                                     
               TOTAL WITH SUMMARIES        239                                     
               TOTAL WITH STATEMENTS        10