510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2017
DEVICE: Planmed Clarity
Planmed Oy 510(k) NO: K163328(Traditional)
ATTN: Lars Moring PHONE NO : 358 20 7795300
Sorvaajankatu 7 SE DECISION MADE: 28-DEC-17
Helsinki FI FI-00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pobling MIITY 2
HABALAN MED & BEAUTY CO.,LTD 510(k) NO: K163550(Traditional)
ATTN: RAY JEON PHONE NO : 82 2 8569450
907, 219, GASANDIGITAL 1-RO, GEUMCSE DECISION MADE: 20-DEC-17
SEOUL KR 08501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG Acquisition Systems
VALES & HILLS BIOMEDICAL TECH. LTD510(k) NO: K163607(Traditional)
ATTN: Jianfang Liu PHONE NO : 0086 010 51665545 821
No.2 North Street Jingyuan BeijingSE DECISION MADE: 15-DEC-17
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
DAKO DENMARK A/S 510(k) NO: K170005(Traditional)
ATTN: LASSE POST MOLLER PHONE NO : 45 44 859500
PRODUKTIONSVEJ 42 SE DECISION MADE: 21-DEC-17
GLOSTRUP DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
DAKO DENMARK A/S 510(k) NO: K170028(Traditional)
ATTN: Lasse Post Moller PHONE NO : 45 44 859500
PRODUKTIONSVEJ 42 SE DECISION MADE: 21-DEC-17
GLOSTRUP DK 2600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
INTERNATIONAL BIOPHYSICS CORPORATI510(k) NO: K170029(Traditional)
ATTN: Geoff Marcek PHONE NO :
2101 E. ST. ELMO ROAD SE DECISION MADE: 15-DEC-17
AUSTIN TX 78744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lilium a-200E
Lilium Otsuka Co., Ltd. 510(k) NO: K170046(Traditional)
ATTN: Hiroaki Takahashi PHONE NO : 81 42 7043822
4-12-6, Chiyoda, Chuo-ku SE DECISION MADE: 07-DEC-17
Sagamihara city JP 252-0237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPACT S
DMETEC CO., LTD. 510(k) NO: K170104(Traditional)
ATTN: Lee Seung Dae PHONE NO : 82 70 47167195
#402-603. Techno-Park, 193, YakdaeSE DECISION MADE: 27-DEC-17
Gyeonggi-do KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURONAUTE
BIOSERENITY 510(k) NO: K170138(Traditional)
ATTN: Quang TRAN PHONE NO : 331 5727 4271
47 boulevard de l'Hopital SE DECISION MADE: 26-DEC-17
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osteo-P Bone Graft Substitute
Molecular Matrix, Inc. 510(k) NO: K170165(Traditional)
ATTN: Charles Lee PHONE NO : 916 7656196
3410 Industrial Blvd., Suite 103 SE DECISION MADE: 29-DEC-17
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Blood Collection Device for Single Use
Gemtier Medical (Shanghai) Inc. 510(k) NO: K170276(Traditional)
ATTN: Lenny Cao PHONE NO : 86 021 67360886
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 11-DEC-17
Shanghai CN 201502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable High Pressure Syringe
Union Medical Shenzhen Co., Ltd. 510(k) NO: K170279(Traditional)
ATTN: Wenguo Zhang PHONE NO : 86 755 88898501
Room 603, Building 3, Fantasia MICSE DECISION MADE: 12-DEC-17
Shenzhen CN 518062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAURUS PEEK Cage System
Medyssey USA, Inc. 510(k) NO: K170389(Traditional)
ATTN: Shawn Kim PHONE NO : 1 847 4270200
1550 East Higgins Road, Suite 123 SE DECISION MADE: 14-DEC-17
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Implant System
S.I.N. – Sistema de Implante Nacio510(k) NO: K170392(Traditional)
ATTN: Denis Oliveira PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 01-DEC-17
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers Apex Humeral Stems
Arthrex Inc. 510(k) NO: K170414(Traditional)
ATTN: David L. Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 14-DEC-17
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V10
Mediana Co., Ltd. 510(k) NO: K170497(Traditional)
ATTN: Kim Min-hye PHONE NO : 82 337 425400
132, Donghwagongdan-ro, Munmak-eupSE DECISION MADE: 15-DEC-17
Wonju-si KR 220-801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altus Spine Interbody Fusion System
Altus Partners, LLC 510(k) NO: K170553(Traditional)
ATTN: Mark Melton PHONE NO : 901 4974193
1340 Enterprise Drive SE DECISION MADE: 01-DEC-17
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portex Blue Line Ultra Paediatric Tracheosomy Tube
Smiths Medical ASD, Inc. 510(k) NO: K170720(Traditional)
ATTN: James Taufen PHONE NO : 763 3833174
6000 Nathan Lane North SE DECISION MADE: 07-DEC-17
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAM CRRT Unit, SAM Cassette CRRT
Spectral Medical Inc. 510(k) NO: K170790(Abbreviated)
ATTN: Danijela Domljanovic PHONE NO : 416 6263233
135 The West Mall, Unit 2 SE DECISION MADE: 13-DEC-17
Toronto CA M9C 1C2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: wettrust D2care
Wettrust Korea Co., Ltd. 510(k) NO: K170797(Traditional)
ATTN: Sungho Lee PHONE NO : 82 317 198394
312 The Prau, 27 Jeongjail-ro, BunSE DECISION MADE: 06-DEC-17
Seongnam KR 463-480 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Craniomaxillofacial Distraction System (CMFD)
Synthes USA Products, LLC 510(k) NO: K170818(Traditional)
ATTN: Nicholas Fountoulakis PHONE NO : 610 7196553
1301 Goshen Parkway SE DECISION MADE: 07-DEC-17
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Insulin Pen Needle
Jiangsu Caina Technology Co., Ltd.510(k) NO: K170846(Traditional)
ATTN: Jun Lu PHONE NO : 86 510 86205183
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 13-DEC-17
Jiangyin CN 214425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
Solace Therapeutics, Inc. 510(k) NO: K170862(Traditional)
ATTN: Scott Blood PHONE NO : 508 2831200
135 Newbury St SE DECISION MADE: 19-DEC-17
Framingham MA 01701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISP Safety Huber Needle Infusion Set
Infusion Safety Products, Inc. 510(k) NO: K170881(Traditional)
ATTN: Alan P. Reid PHONE NO : 603 3578733
26 Victoria Court SE DECISION MADE: 14-DEC-17
Keene NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wittich Nitinol Stone Basket
Cook Incorporated 510(k) NO: K170898(Traditional)
ATTN: Erum B. Nasir PHONE NO : 812 3353575 102607
750 Daniels Way P.O. Box 489 SE DECISION MADE: 12-DEC-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Composite Removable Sinus Stent System
STS Medical 510(k) NO: K170913(Traditional)
ATTN: Lena Shlossberg PHONE NO : 972 54 7387188
37 Amal SE DECISION MADE: 15-DEC-17
Petah Tikva IL 4951337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C3 Wave System
Medical Components, Inc (Dba Medco510(k) NO: K170934(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201 2285
1499 Delp Drive SE DECISION MADE: 06-DEC-17
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well-Root ST
Vericom Co., Ltd. 510(k) NO: K170950(Traditional)
ATTN: Hyoshin Chung PHONE NO : 82 31 4412881
48, Toegyegongdan 1-Gil, SE DECISION MADE: 20-DEC-17
Chuncheon-Si KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoaguChek Vantus System
Roche Diagnostics 510(k) NO: K170960(Traditional)
ATTN: Justin Davis PHONE NO : 317 5216204
9115 Hague Road SE DECISION MADE: 25-DEC-17
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apex Tibial Nailing System
OrthoXel 510(k) NO: K170972(Traditional)
ATTN: Aisling O'Sullivan PHONE NO : 35 321 2429700
Rubicon Center Cork Institute of TSE DECISION MADE: 20-DEC-17
Bishopstown IE T12 Y275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DropSafe Safety Pen Needle
HTL-Strefa S.A. 510(k) NO: K170988(Traditional)
ATTN: Aleksandra Prazmowska-WilanPHONE NO : 48 42 2700010
Adamowek 7 SE DECISION MADE: 12-DEC-17
Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
Inova Diagnostics, Inc. 510(k) NO: K170993(Traditional)
ATTN: Roger Albesa PHONE NO : 858 5869900 1391
9900 Old Grove Road SE DECISION MADE: 22-DEC-17
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veraview X800
J.Morita USA, Inc. 510(k) NO: K171012(Traditional)
ATTN: Keisuke Mori PHONE NO : 949 5819600
9 Mason SE DECISION MADE: 19-DEC-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PoreStar Patient Specific Implant
Anatomics Pty Ltd 510(k) NO: K171037(Traditional)
ATTN: Joanne Flatley PHONE NO : 61 03 95298088
23-27 Wellington St SE DECISION MADE: 27-DEC-17
St Kilda AU 3182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
Coloplast Corp 510(k) NO: K171043(Traditional)
ATTN: Cori Ragan PHONE NO : 612 5975106
1601 West River Road North SE DECISION MADE: 21-DEC-17
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Real Time Image Gating System for Proton Beam Therapy Systems
Hitachi, Ltd. Healthcare 510(k) NO: K171049(Traditional)
ATTN: Tomoyuki Seino PHONE NO : 81 3 62843741
2-16-1 Higachi-Ueno, Taito-ku SE DECISION MADE: 26-DEC-17
Tokyo JP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medacta Shoulder System: Threaded Glenoid Baseplate
Medacta International SA 510(k) NO: K171058(Traditional)
ATTN: Stefano Baj PHONE NO : 41 916 966060
Strada Regina SE DECISION MADE: 13-DEC-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRSASelect II
Bio-Rad 510(k) NO: K171061(Traditional)
ATTN: Sylvie Fernez PHONE NO : 33 1 47956282
3 Boulevard Raymond Poincare SE DECISION MADE: 28-DEC-17
92430 Marnes-la-Coquette FR 92430510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ives MR Conditional Cup Electrode
Ives EGG Solutions 510(k) NO: K171102(Traditional)
ATTN: John Ives PHONE NO : 978 3588006
25 Storey Avenue, #118 SE DECISION MADE: 21-DEC-17
Newburyport MA 01950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOBAHN Nailing System
Globus Medical Inc. 510(k) NO: K171108(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 29-DEC-17
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Praxiject 0.9% NaCl
MedXL Inc. 510(k) NO: K171109(Traditional)
ATTN: Premala Premanathan PHONE NO : 1 514 6957474
285 Av Labrosse SE DECISION MADE: 21-DEC-17
Pointe-Claire CA H9R 1A3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prodigio Stain Powder
OperArt LLC 510(k) NO: K171167(Traditional)
ATTN: Domenico Cascione PHONE NO : 310 5147056
1551 Ocean Ave., Suite 220 SE DECISION MADE: 13-DEC-17
Santa Monica CA 90401 510(k) STATEMENT
DEVICE: PERIO-FLOW nozzle
E.M.S. Electro Medical Systems S.A510(k) NO: K171174(Traditional)
ATTN: Suzanne Fassio-Hardy PHONE NO : 41 22 9944771
31 CH. de la Vuarpilliere SE DECISION MADE: 18-DEC-17
Nyon CH ch-1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IR Type Implant System
Biotem Co., Ltd. 510(k) NO: K171185(Traditional)
ATTN: Hong Koo Yeo PHONE NO : 82 708 2204934
57, Sasang-ro , 401 beon-gil SasanSE DECISION MADE: 01-DEC-17
Busan KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cerebrotech CMS-5000
Cerebrotech Medical Systems 510(k) NO: K171186(Traditional)
ATTN: Dawnel Scott PHONE NO : 510 5016571
1048 Serpentine Lane Suite 301 SE DECISION MADE: 08-DEC-17
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Certa Catheter
Ferrosan Medical Devices SP. Z O.O510(k) NO: K171193(Traditional)
ATTN: Elzbieta Porebska-GuillemanPHONE NO : 48 91 4283400
Koksowa 3 SE DECISION MADE: 18-DEC-17
Szczecin PL 70-031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuViz 16 Essence Multi-slice CT Scanner System
Neusoft Medical Systems Co., Ltd. 510(k) NO: K171198(Traditional)
ATTN: Shao Xiancheng PHONE NO : 86 248 3660645
No. 16, Shiji Road Hunnan IndustriSE DECISION MADE: 07-DEC-17
Shenyang CN 110179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-PSI Knee System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K171269(Traditional)
ATTN: Guylaine Roy PHONE NO : 514 8614074 231
75 Queen Street Suite 3300 SE DECISION MADE: 28-DEC-17
Montreal CA h3c 2n6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polyform Synthetic Mesh
Boston Scientific Corporation 510(k) NO: K171271(Special)
ATTN: Michelle Berry PHONE NO : 508 6834344
100 Boston Scientific Way SE DECISION MADE: 15-DEC-17
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
Cook Incorporated 510(k) NO: K171275(Special)
ATTN: Daniel J. Corbin PHONE NO : 812 3353575 104018
750 Daniels Way SE DECISION MADE: 20-DEC-17
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Henke-Sass, Wolf GmbH 510(k) NO: K171336(Traditional)
ATTN: Anna Reifschneider PHONE NO : 49 7462 9466147
Keltenstrasse 1 SE DECISION MADE: 07-DEC-17
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZFluence
Radformation, Inc. 510(k) NO: K171352(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue 16th Floor SE DECISION MADE: 01-DEC-17
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adhesive Electrodes
ShenZhen Quality Medical Technolog510(k) NO: K171381(Traditional)
ATTN: Grace Zhao PHONE NO : 86 755 29016583
5/F, Plant C3, No.1, Nuclear PowerSE DECISION MADE: 13-DEC-17
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCCIA® MultiLIF
Silony Medical GmbH 510(k) NO: K171434(Traditional)
ATTN: Bircan Yilmaz PHONE NO : 49 711 78252540
Leinfelder Strasse 60 SE DECISION MADE: 21-DEC-17
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxyPure Color Silicone Hydrogel Soft Contact Lenses
Visco Vision Inc 510(k) NO: K171447(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 05-DEC-17
Taoyuan City TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
i-SENS, Inc. 510(k) NO: K171480(Special)
ATTN: Joon Ho Jung PHONE NO : 82 2 9100453
43, Banpo-daero 82-gil, Seocho-gu SE DECISION MADE: 13-DEC-17
Seoul KR 06646 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArchFlo CT Midline
Medcomp (dba Medical Components, I510(k) NO: K171483(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 15-DEC-17
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lunderquist Extra Stiff Wire Guide
William Cook Europe ApS 510(k) NO: K171513(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 56 868756
Sandet 6 SE DECISION MADE: 07-DEC-17
Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deltaven XiV Max, Deltaven XiV Max FF
Delta Med SpA 510(k) NO: K171530(Traditional)
ATTN: Raschi Olga PHONE NO : 39 037 5785915
Via Guido Rossa N 20 SE DECISION MADE: 21-DEC-17
Viadana IT 46019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Cepheid 510(k) NO: K171552(Dual Track)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 19-DEC-17
Sunnyvale CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W&H Assistina Twin
W & H Dentalwerk Buermoos GmbH 510(k) NO: K171553(Traditional)
ATTN: Mag. Anja Lindner PHONE NO : 0043 6274 6236397
Ignaz-Glaser-StraBe 53 SE DECISION MADE: 08-DEC-17
Buermoos AT 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Wilson-Cook Medical, Inc. 510(k) NO: K171573(Traditional)
ATTN: Sierra Lowe PHONE NO : 336 7440157 396506
4900 Bethania Station Road SE DECISION MADE: 29-DEC-17
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuro Omega System
Alpha Omega Engineering Ltd, 510(k) NO: K171581(Traditional)
ATTN: Maysana Mousa PHONE NO : 972 4 6563327
Nazareth Industrial Park, Mount PrSE DECISION MADE: 22-DEC-17
Nazareth IL 1612102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. Braun Tear-Away Introducer Needle
B. Braun Medical Inc. 510(k) NO: K171584(Traditional)
ATTN: Kimberly Smith PHONE NO : 610 5962326
901 Marcon Blvd. SE DECISION MADE: 22-DEC-17
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Double Lumen Ovum Aspiration Needles
William A. Cook Australia Pty Ltd 510(k) NO: K171611(Special)
ATTN: Gordana Pozvek PHONE NO : 61 7 38411188
95 Brandl Street SE DECISION MADE: 15-DEC-17
Eight Mile Plains AU 4113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Guide SCENERGY
Clear Guide Medical 510(k) NO: K171677(Traditional)
ATTN: Jack Kent PHONE NO : 410 9297720
3600 Clipper Mill Road, Suite 400 SE DECISION MADE: 08-DEC-17
Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixtemp C&B
Dreve Dentamid GmbH 510(k) NO: K171729(Traditional)
ATTN: Reiner Altmann PHONE NO : 49 230 3880714
Max-Planck-StraBe 31 SE DECISION MADE: 13-DEC-17
Unna DE 59423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Ansell Healthcare Products LLC 510(k) NO: K171737(Traditional)
ATTN: Robert Mahler PHONE NO : 732___ 3452174
111 Wood Avenue South, Suite 210 SE DECISION MADE: 29-DEC-17
Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrification Kit and Thawing Kit
Kitazato Corporation 510(k) NO: K171748(Traditional)
ATTN: Futoshi Inoue PHONE NO : 81 545 662202
81 Nakajima SE DECISION MADE: 14-DEC-17
Fuji JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K171771(Traditional)
ATTN: Alan Haley PHONE NO : 302 6319883
500 GBC Drive SE DECISION MADE: 04-DEC-17
Newark DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann n!ce Glass Ceramic A14 Blocks
Institut Straumann AG 510(k) NO: K171773(Traditional)
ATTN: Shokoufeh Khodabandeh PHONE NO : 41 61 9651225
Peter Merian Weg 12 SE DECISION MADE: 01-DEC-17
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eVox System
Evoke Neuroscience, Inc. 510(k) NO: K171781(Traditional)
ATTN: David Hagedorn PHONE NO : 917 2616096
200 Valencia Dr. Suite 109 SE DECISION MADE: 13-DEC-17
Jacksonville NC 28546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G Surgical OCT Spinal System
G Surgical LLC 510(k) NO: K171834(Traditional)
ATTN: Donald Grafton PHONE NO : 512 4944749
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 19-DEC-17
Austin TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
Globus Medical Inc. 510(k) NO: K171848(Traditional)
ATTN: Lori Burns PHONE NO : 610 9301800 2950
2560 General Armistead Ave. SE DECISION MADE: 21-DEC-17
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sidus Stem-Free Shoulder
Zimmer GmbH 510(k) NO: K171858(Traditional)
ATTN: Roberto Tommasini PHONE NO : 41 588 548264
Sulzer Allee 8 SE DECISION MADE: 18-DEC-17
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentrant Introducer Sheath with Hydrophilic Coating
Medtronic Vascular, Inc. 510(k) NO: K171866(Special)
ATTN: Wee Wen Leow PHONE NO : 707 5917703
3576 Unocal Place SE DECISION MADE: 20-DEC-17
Santa Rosa CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLM-1ER, SLM-2ER, SLM-3ER
Chongqing Kanghua Ruiming S&T Co.,510(k) NO: K171877(Traditional)
ATTN: Xi You PHONE NO : 86 23 63227333
No.5, Road1, Tongjiaxi Industrial SE DECISION MADE: 21-DEC-17
Chongqing CN 400070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reusable Blood Pressure Cuff
Suzhou Minhua Medical Apparatus Su510(k) NO: K171889(Traditional)
ATTN: Yang Qidong PHONE NO : 86 21 59840221
You Yi Industrial Park, Songlin ToSE DECISION MADE: 19-DEC-17
Suzhou CN 215222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAL for Medical Use (Lower Limb Type)
CYBERDYNE Inc. 510(k) NO: K171909(Traditional)
ATTN: Yohei Suzuki PHONE NO : 81 29 8698453
2-2-1 Gakuen-Minami SE DECISION MADE: 17-DEC-17
Tsukuba JP 305-0818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med-Hot Thermal Imaging Systems
Med-Hot Thermal Imaging Inc. 510(k) NO: K171928(Traditional)
ATTN: Carol Chandler PHONE NO : 863 6461599
5120 S. Florida Ave. Suite 301 SE DECISION MADE: 08-DEC-17
Lakeland FL 33813 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alevicyn SG Antimicrobial Gel
Sonoma Pharmaceuticals, Inc. 510(k) NO: K171935(Traditional)
ATTN: Brian W. Martin PHONE NO : 707 2830550
1129 N. McDowell Boulevard SE DECISION MADE: 01-DEC-17
Petaluma CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Endoscope Biopsy Sampling Needle
Changzhou Detain Medical Devices C510(k) NO: K171956(Traditional)
ATTN: Zhengrong Ding PHONE NO : 86 519 69805285
No.47, North Qingyang Rd, TianningSE DECISION MADE: 12-DEC-17
Changzhou CN 213017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofia Strep A+ FIA, Sofia 2 Analyzer
Quidel Corporation 510(k) NO: K171976(Dual Track)
ATTN: Edward C. Brehm PHONE NO : 1 858 5521100 21015
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 21-DEC-17
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Humerus System
Jeil Medical Corporation 510(k) NO: K172008(Traditional)
ATTN: Sejin Ryu PHONE NO : 82 2 8503583
702.703.704.705.706.804.805.807.81SE DECISION MADE: 01-DEC-17
Seoul KR 152-728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cascadia Interbody System
K2M, Inc. 510(k) NO: K172009(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
600 Hope Parkway SE SE DECISION MADE: 14-DEC-17
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gel-e Bandage
gel-e, Inc. (formerly Remedium Tec510(k) NO: K172010(Traditional)
ATTN: Matthew Dowling PHONE NO : 1 301 4053585
387 Technology Dr., Ste 3110B SE DECISION MADE: 07-DEC-17
College Park MD 20742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex DynaNite Nitinol Staple
Arthrex Inc. 510(k) NO: K172052(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 13-DEC-17
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnoSight Diagnostic Ultrasound System
Qisda Corporation 510(k) NO: K172056(Traditional)
ATTN: Johnson Sheu PHONE NO : 886 3359 5000 3822
No.157, Shanying Rd., Gueishan DisSE DECISION MADE: 13-DEC-17
Taoyuan City TW 333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhotoFix Decellularized Bovine Pericardium
CryoLife, Inc. 510(k) NO: K172085(Traditional)
ATTN: Heather Emerick PHONE NO : 770 4193355 4502
1655 Roberts Blvd. NW SE DECISION MADE: 04-DEC-17
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T
Shenzhen Jamr Medical Technology C510(k) NO: K172171(Traditional)
ATTN: Li Xue PHONE NO : 86 0755 85292057
2nd Floor, A-building, No.2 GuiyuaSE DECISION MADE: 21-DEC-17
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical PT Interbody Spacer System
Tyber Medical LLC 510(k) NO: K172185(Traditional)
ATTN: Mark F. Schenk PHONE NO : 610 8490645
83 South Commerce Way, SE DECISION MADE: 21-DEC-17
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
Cook Incorporated 510(k) NO: K172217(Traditional)
ATTN: Andrew Breidenbach PHONE NO : 812 3392235 104901
750 Daniels Way SE DECISION MADE: 13-DEC-17
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8ch Flex Suite
Shenzhen RF Tech Co., Ltd. 510(k) NO: K172222(Traditional)
ATTN: Ke Xi PHONE NO : 086 755 26641989
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 08-DEC-17
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pioli IOL Delivery System
AST Products, Inc. 510(k) NO: K172228(Traditional)
ATTN: William Lee PHONE NO : 978 6674500
9 Linnell Circle SE DECISION MADE: 15-DEC-17
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREline Airless Hemodialysis Blood Tubing Sets
Fresenius Medical Care Renal Thera510(k) NO: K172238(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 14-DEC-17
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
Beckman Coulter, Inc 510(k) NO: K172255(Traditional)
ATTN: Shannon Popson PHONE NO : 916 3743330
1584 Enterprise Blvd SE DECISION MADE: 01-DEC-17
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
True Diagnostics, Inc 510(k) NO: K172257(Traditional)
ATTN: Jerry Lee PHONE NO :
2782 Loker Ave West SE DECISION MADE: 22-DEC-17
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gammaCore-2
eletroCore, LLC 510(k) NO: K172270(Traditional)
ATTN: Mike Romaniw PHONE NO : 973 2900097
150 Allen Road, Suite 201 SE DECISION MADE: 07-DEC-17
Basking Ridge NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xario 200 Diagnostic Ultrasound System V6.0
Toshiba Medical Systems Corporatio510(k) NO: K172276(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 12-DEC-17
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automated Blood Coagulation Analyzer CS-2500
Siemens Healthcare Diagnostic Prod510(k) NO: K172286(Traditional)
ATTN: Nils Neumann PHONE NO : 49 6421 397133
Emil-von Behring Strasse 76 SE DECISION MADE: 18-DEC-17
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode PLUS System
InMode MD Ltd. 510(k) NO: K172302(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building Shaar Yokneam SE DECISION MADE: 08-DEC-17
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFlux Device
Biotricity Inc. 510(k) NO: K172311(Third Party - Traditional)
ATTN: Spencer LaDow PHONE NO : 416 2144216
275 Shoreline Drive, Suite 150 SE DECISION MADE: 15-DEC-17
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Cook Incorporated 510(k) NO: K172321(Special)
ATTN: Naomi Funkhouser PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489 SE DECISION MADE: 21-DEC-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blustone Synergy Silica System
Blustone Synergy 510(k) NO: K172330(Traditional)
ATTN: Lisa Peterson PHONE NO : 512 5070746
5520 Ventana Ct. SE DECISION MADE: 21-DEC-17
Pueblo CO 81005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
Beckman Coulter, Inc. 510(k) NO: K172337(Traditional)
ATTN: Teresa S. Wong PHONE NO : 916 3742432
1584 Enterprise Blvd. SE DECISION MADE: 15-DEC-17
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InFill® Interbody Fusion Device
Pinnacle Spine Group, LLC 510(k) NO: K172349(Traditional)
ATTN: Zach Sowell PHONE NO : 214 4661428
2921 Canton St. SE DECISION MADE: 14-DEC-17
Dallas TX 75226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AxSOS 3 Ti
Stryker GmbH 510(k) NO: K172350(Traditional)
ATTN: Kemine Hale PHONE NO : 41 32 6416935
Bohnackerweg 1 SE DECISION MADE: 15-DEC-17
Selzach CH 2545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
EVER GROWTH (VIETNAM) CO., LTD 510(k) NO: K172357(Abbreviated)
ATTN: Che-Min Lee PHONE NO : 84 127 3926920
Long Khanh Industrial Zone, Binh LSE DECISION MADE: 29-DEC-17
Long Khanh Township VN 810000 510(k) STATEMENT
DEVICE: Arthrosurface Bone Screws
Arthrosurface, Inc. 510(k) NO: K172383(Traditional)
ATTN: Dawn J. wilson PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 22-DEC-17
Franklin MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPOD ITPR
Advanced Circulatory System, a who510(k) NO: K172388(Traditional)
ATTN: Anja Metzger PHONE NO : 651 2261626
ZOLL 1905 County Rd C West SE DECISION MADE: 22-DEC-17
Roseville MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNIPER STAPLE SYSTEM, NON-STERILE
Trilliant Surgical 510(k) NO: K172405(Traditional)
ATTN: Jon Olson PHONE NO : 800 4952919
6721 Portwest Drive SE DECISION MADE: 11-DEC-17
Houston TX 77024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velofix™ TLIF Cage
U&i Corporation 510(k) NO: K172419(Traditional)
ATTN: Jee-Ae Bang PHONE NO : 82 31 8606846
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 04-DEC-17
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoPediatrics Wrist Fusion Plate
OrthoPediatrics, Inc. 510(k) NO: K172425(Traditional)
ATTN: Adam Cargill PHONE NO : 574 2686379
2850 Frontier Drive SE DECISION MADE: 06-DEC-17
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SporView Rapid Read Biological Indicator
Crosstex/SPSmedical, A Division of510(k) NO: K172432(Traditional)
ATTN: Megan Skaar PHONE NO : 800 7221529
6789 West Henrietta Road SE DECISION MADE: 12-DEC-17
Rush NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RoyalGuard Surgical Gown, i600, Breathable
GRI Medical & electrical Technolog510(k) NO: K172445(Traditional)
ATTN: Martin D. Paugh PHONE NO : 86 135 11359722
1805 Honggao rd., Xiuzhou IndustrySE DECISION MADE: 08-DEC-17
Jiaxing CN 314031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Riptide Aspiration System
Micro Therapeutics, Inc., d/b/a ev510(k) NO: K172448(Traditional)
ATTN: Ryan Kenney PHONE NO : 949 2975489
9775 Toledo Way SE DECISION MADE: 21-DEC-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idys™ TLIF 3DTi Cages
CLARIANCE, SAS 510(k) NO: K172465(Traditional)
ATTN: Pascal Rokegem PHONE NO : 33 03 21161215
18 rue Robespierre SE DECISION MADE: 15-DEC-17
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI ARC Anteverted Neck Hip Stem
OMNIlife science 510(k) NO: K172467(Traditional)
ATTN: Christina Rovaldi PHONE NO : 774 2261857
480 Paramount Drive SE DECISION MADE: 21-DEC-17
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
InNeuroCo, Inc 510(k) NO: K172468(Traditional)
ATTN: Marc Litzenberg PHONE NO : 954 4725988
4635 NW 103rd Avenue SE DECISION MADE: 06-DEC-17
Sunrise FL 33351 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeStyles® SKYN® Intimate Moments Personal Lubricant
SXWELL USA LLC 510(k) NO: K172473(Traditional)
ATTN: Robert Mahler PHONE NO : 732 3452174
111 Wood Avenue South, Suite 210 SE DECISION MADE: 15-DEC-17
Iselin NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Celerity 20 HP Biological Indicator
Steris Corporation 510(k) NO: K172474(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 1 440 3927437
5960 Heisley Road SE DECISION MADE: 29-DEC-17
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Nellcor pulse oximetry monitor interface cable
Covidien 510(k) NO: K172482(Traditional)
ATTN: Mia M. Ware PHONE NO : 303 3052750
6135 Gunbarrel Avenue SE DECISION MADE: 15-DEC-17
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEUS PTA Balloon Catheter with Embolic Capture Feature
Angioslide, Ltd. 510(k) NO: K172494(Special)
ATTN: Eran Vickus PHONE NO : 972 4 7904600
4 Ha'Omanut Street, Poleg IndustriSE DECISION MADE: 15-DEC-17
Netanya IL 4250438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Conditional Cup Electrode, MR Conditional Webb Electrode
Rhythmlink International, LLC 510(k) NO: K172503(Traditional)
ATTN: Daniel McCoy PHONE NO : 803 2521222
1140 First Street South SE DECISION MADE: 01-DEC-17
Columbia SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
MIS Implants Technologies Ltd. 510(k) NO: K172505(Traditional)
ATTN: Arbel Shezaf PHONE NO : 972 4 9016800
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 28-DEC-17
Bar Lev Industrial Park IL 201560510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO
ImpediMed Limited 510(k) NO: K172507(Traditional)
ATTN: Catherine Kingsford PHONE NO : 61 7 38603703
Unit 1 50 Parker Court SE DECISION MADE: 22-DEC-17
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivaer ARC Stylus
Aerin Medical, Inc. 510(k) NO: K172529(Traditional)
ATTN: Shannon Scott PHONE NO : 512 2219956
232 E. Caribbean Drive SE DECISION MADE: 05-DEC-17
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIFIL Flow Plus X
Shofu Dental Corporation 510(k) NO: K172530(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277
1225 Stone Drive SE DECISION MADE: 06-DEC-17
San Marcos CA 92078 510(k) STATEMENT
DEVICE: PREMIUM ONE Implant Systems
Sweden & Martina S.p.A 510(k) NO: K172560(Traditional)
ATTN: Alessia Pezzato PHONE NO : 39 049 9124300
via Veneto, 10 SE DECISION MADE: 21-DEC-17
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: Disposable Circular Stapler
Changzhou Kangdi Medical Stapler C510(k) NO: K172561(Special)
ATTN: Eve Zhou PHONE NO : 86 519 85162780
No.16 Kunlun Road, XinBei Zone SE DECISION MADE: 05-DEC-17
Changzhou City CN 213022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Boston Scientific Corporation 510(k) NO: K172565(Traditional)
ATTN: Anand Patel PHONE NO : 508 6835320
100 Boston Scientific Way SE DECISION MADE: 20-DEC-17
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReBOSSIS85
Orthorebirth Co., Ltd. 510(k) NO: K172573(Traditional)
ATTN: Yasutoshi Nishikawa PHONE NO : 81 455 323650
3-17-43 Chigasaki Higashi SE DECISION MADE: 15-DEC-17
Tsuzuki-ku Yokohama JP 224-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Equipment Pouch
WickiMed(Huizhou)Medical Equipment510(k) NO: K172578(Traditional)
ATTN: Haobin Li PHONE NO : 86 075 23860807
Tang Jiao Xing Wang Street, Lilin SE DECISION MADE: 07-DEC-17
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proficient® Posterior Cervical Spine System
Spine Wave, Inc. 510(k) NO: K172594(Traditional)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive Suite 210 SE DECISION MADE: 15-DEC-17
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K172618(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 05-DEC-17
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Navigation Instruments
NuVasive, Incorporated 510(k) NO: K172623(Traditional)
ATTN: Manthan J. Damani PHONE NO : 858 4582272
7475 Lusk Blvd. SE DECISION MADE: 21-DEC-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc. 510(k) NO: K172629(Traditional)
ATTN: Anila K Tarte PHONE NO : 858 4108055
10210 Genetic Center Drive SE DECISION MADE: 04-DEC-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLux Instrument, iLux Disposable
Tear Film Innovations, Inc. 510(k) NO: K172645(Traditional)
ATTN: John Slate PHONE NO : 844 4589776
12625 High Bluff Drive, Suite 107 SE DECISION MADE: 26-DEC-17
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FMP Extended Liners
Encore Medical, L.P. 510(k) NO: K172651(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 13-DEC-17
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
SutureEase, Inc. 510(k) NO: K172666(Traditional)
ATTN: Scott Heneveld PHONE NO : 408 4597595
1735 N First Street, Suite 300 SE DECISION MADE: 01-DEC-17
San Jose CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Modulus-C Interbody System
NuVasive, Incorporated 510(k) NO: K172676(Traditional)
ATTN: Marysa E. Loustalot PHONE NO : 858 3204515
7475 Lusk Boulevard SE DECISION MADE: 14-DEC-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage Plus Pass-Thru
Medivators Inc. 510(k) NO: K172677(Traditional)
ATTN: Megan Skaar PHONE NO : 763 5533369
14605 28th Avenue North SE DECISION MADE: 19-DEC-17
Minneapolis MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Align Radial Head System
Skeletal Dynamics, LLC 510(k) NO: K172688(Special)
ATTN: Ana M. Escagedo PHONE NO : 305 5967585
8905 SW 87 Avenue, Suite 201 SE DECISION MADE: 22-DEC-17
Miami FL 33176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Tangible Science LLC 510(k) NO: K172692(Traditional)
ATTN: Vic McCray PHONE NO : 650 2411045
173 Jefferson Drive SE DECISION MADE: 13-DEC-17
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GammaPod - Model A
Xcision Medical Systems, LLC 510(k) NO: K172706(Traditional)
ATTN: Daniel R. Plonski PHONE NO : 443 6817468
9176 Red Branch Road, Suite O SE DECISION MADE: 22-DEC-17
Columbia MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renamel Microfill
Cosmedent, Inc 510(k) NO: K172707(Traditional)
ATTN: Mary Nowak PHONE NO : 312 6449586
401 N. Michigan Ave, Suite 2500 SE DECISION MADE: 05-DEC-17
Chicago IL 60611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
Fujirebio Diagnostics, Inc. 510(k) NO: K172713(Traditional)
ATTN: Stacey Dolan PHONE NO : 610 2403843
201 Great Valley Parkway SE DECISION MADE: 10-DEC-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LipiVage
Genesis Biosystems, Inc. 510(k) NO: K172714(Traditional)
ATTN: Jim Lafferty PHONE NO : 972 3157888 102
1500 Eagle Court SE DECISION MADE: 08-DEC-17
Lewisville TX 75057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
EUROIMMUN US, Inc. 510(k) NO: K172722(Traditional)
ATTN: Michael A. Locke PHONE NO : 973 6561000 105
1 Bloomfield Ave. SE DECISION MADE: 10-DEC-17
Mountain Lakes NJ 07046 510(k) STATEMENT
DEVICE: VITEK 2 AST-GN Amikacin (=64 ug/mL)
bioMerieux, Inc. 510(k) NO: K172731(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Road SE DECISION MADE: 08-DEC-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 8
ALPINION MEDICAL SYSTEMS Co., Ltd.510(k) NO: K172732(Traditional)
ATTN: Boyeon CHO PHONE NO : 82 70 74652104
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 14-DEC-17
Seoul KR 08393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Electrosurgical Snare SD-400
Olympus Medical Systems Corp. 510(k) NO: K172734(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 07-DEC-17
Hachioji JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESIRE - Balloon Sinus Dilatation System
M/s. Meril Life Sciences Private L510(k) NO: K172737(Traditional)
ATTN: Umesh Sharma PHONE NO : 91 0260 3052100
Survey No. 135/139, Bilakhia HouseSE DECISION MADE: 12-DEC-17
Chala, Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natus VikingQuest
Natus Neurology Incorporated 510(k) NO: K172743(Special)
ATTN: Shane T. Sawall PHONE NO : 608 8298673
3150 Pleasant View Road SE DECISION MADE: 19-DEC-17
Middleteon WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Varian cage
Medyssey USA, Inc. 510(k) NO: K172756(Traditional)
ATTN: Shawn Kim PHONE NO : 847 4270200
1550 E. Higgins Road, Suite 123 SE DECISION MADE: 08-DEC-17
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONQUEST FN
Smith & Nephew 510(k) NO: K172785(Special)
ATTN: Allison Chan PHONE NO : 901 3991098
1450 E Brooks Road SE DECISION MADE: 22-DEC-17
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDS Plating System
Miami Device Solutions, LLC 510(k) NO: K172786(Traditional)
ATTN: Michelle Montesino PHONE NO : 786 4221400 106
7620 NW 25th Street, Unit 3 SE DECISION MADE: 08-DEC-17
Miami FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightWalker Laser System Family
Fotona d.o.o. 510(k) NO: K172819(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009299
Stegne 7 SE DECISION MADE: 01-DEC-17
Ljubljana SI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies 510(k) NO: K172844(Traditional)
ATTN: Veronique Dentan PHONE NO : 33 1 70080994
9 Rue d'Enghien SE DECISION MADE: 15-DEC-17
Paris FR 75010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEVION S250i Proton Beam Radiation Therapy Device
Mevion Medical Systems 510(k) NO: K172848(Traditional)
ATTN: Thomas H. Faris PHONE NO : 978 5401500
300 Foster St. SE DECISION MADE: 27-DEC-17
Littleton MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelPerfect Abutments
Nobel Biocare AB 510(k) NO: K172854(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 14-DEC-17
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital thermometer(with disposable thermometer cover)
Hangzhou Hua'an medical&health ins510(k) NO: K172861(Special)
ATTN: Ahneo Yang PHONE NO : 86 571 88734065
Building 2, 1# Fuzhu Nan RD, WuchaSE DECISION MADE: 19-DEC-17
Hangzhou CN 310023 510(k) STATEMENT
DEVICE: Infinix-i, INFX-8000V, V7.0
Toshiba Medical Systems Corporatio510(k) NO: K172863(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 14-DEC-17
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerDot PD-01M
Smartmissimo Technologies Pte Ltd 510(k) NO: K172876(Special)
ATTN: Alexey Pisarev PHONE NO : 65 83 216256
#28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 04-DEC-17
Singapore SG 068807 510(k) STATEMENT
DEVICE: Breakaway Screw System
Paragon 28 510(k) NO: K172886(Special)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E Ste 280 SE DECISION MADE: 20-DEC-17
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages
EIT Emerging Implant Technologies 510(k) NO: K172888(Traditional)
ATTN: Barbara Wirth PHONE NO : 49 7461 1716904
Eisenbahnstrasse 84 SE DECISION MADE: 15-DEC-17
Wurmlingen DE 78573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeSept Needle Free Transseptal Guidewire
Pressure Products Medical Device M510(k) NO: K172893(Traditional)
ATTN: Andrew Armour PHONE NO : 610 5432324
1 School Street SE DECISION MADE: 21-DEC-17
Morton PA 19070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliVue Capnography Extension, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen510(k) NO: K172904(Traditional)
ATTN: Markus Stacha PHONE NO : 49 7031 4632840
Hewlett-Packard-Str.-2 SE DECISION MADE: 26-DEC-17
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-Switched Nd:YAG Laser System
AMI Inc. 510(k) NO: K172908(Traditional)
ATTN: Hae Youn Lee PHONE NO : 82 2 3281 9091
RM 1412, SJ Techno Ville, 287 BeotSE DECISION MADE: 07-DEC-17
Seoul KR 08511 510(k) STATEMENT
DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
Beckman Coulter Inc. 510(k) NO: K172912(Traditional)
ATTN: Shannon Popson PHONE NO : 916 3721900
2040 Enterprise Bldv SE DECISION MADE: 07-DEC-17
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
KaVo Dental Technologies, LLC 510(k) NO: K172918(Traditional)
ATTN: Frank Ray PHONE NO : 704 5877227
11727 Fruehauf Drive SE DECISION MADE: 18-DEC-17
Charlotte NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MMPC-4127F1
Barco N.V. 510(k) NO: K172922(Traditional)
ATTN: Lieven De Wandel PHONE NO : 32 5 6233459
President Kennedypark 35 SE DECISION MADE: 21-DEC-17
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Vu cPOD, Zuma-C, Complete Cervical
SeaSpine Orthopedics Corporation 510(k) NO: K172926(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 21-DEC-17
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
Advanced Instrumentations, Inc. 510(k) NO: K172931(Abbreviated)
ATTN: Jorge Millan PHONE NO : 305 4776331
6800 NW 77th Ct SE DECISION MADE: 01-DEC-17
Miami FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: True Flow Valvuloplasty Perfusion Catheter
C. R. Bard, Inc. 510(k) NO: K172932(Traditional)
ATTN: Aaron Conovaloff PHONE NO : 480 3506012
1625 West 3rd Street SE DECISION MADE: 13-DEC-17
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-GN Ceftazidime/Avibactam =16 µg/mL
bioMerieux, Inc. 510(k) NO: K172944(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 19-DEC-17
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Ezisurg Medical Co., Ltd. 510(k) NO: K172960(Traditional)
ATTN: Sheng Tian PHONE NO : 86 21 50456176
Rm. 103, Bldg.2, No.1690 Cailun RoSE DECISION MADE: 21-DEC-17
Shanghai CN 201203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMS-2000 Central Monitoring System
Advanced Instumentations, Inc. 510(k) NO: K172966(Traditional)
ATTN: Jorge Millan PHONE NO : 305 4776331
6800 NW 77th. Ct. SE DECISION MADE: 08-DEC-17
Miami FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Spine Foot and Ankle Plating System
Life Spine Inc. 510(k) NO: K172973(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 21-DEC-17
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgeoBite
Surgovations LLC 510(k) NO: K172978(Traditional)
ATTN: Chris Menard PHONE NO : 478 2541707
110 Fairway Run SE DECISION MADE: 22-DEC-17
Forsyth GA 31029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperGrow 272, Ultimate 272
Super Grow Lasers 510(k) NO: K172982(Traditional)
ATTN: Jeff Stanifer PHONE NO : 713 5516320
1903 Commonwealth Street #16 SE DECISION MADE: 19-DEC-17
Houston TX 77006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zmachine Synergy
Consolidated Research of Richmond,510(k) NO: K172986(Traditional)
ATTN: Richard Kaplan PHONE NO : 216 2892331
26250 Euclid Avenue, Suite 709 SE DECISION MADE: 19-DEC-17
Cleveland OH 44132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump
Joytech Healthcare Co., Ltd. 510(k) NO: K172989(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 20-DEC-17
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P20 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K172993(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f yizhe buSE DECISION MADE: 05-DEC-17
shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K173000(Traditional)
ATTN: Flower Cai PHONE NO : 86 754 88250150
77 Jinsha Road SE DECISION MADE: 07-DEC-17
Shantou CN 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2940 nm Er:Yag Laser Handpiece
Quanta System S.p.A. 510(k) NO: K173002(Traditional)
ATTN: Francesco Dell’Antonio PHONE NO : 39 0331 376797
Via Acquedotto, 109 SE DECISION MADE: 13-DEC-17
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCS 17-01
Anika Therapeutics, Inc. 510(k) NO: K173008(Traditional)
ATTN: Steven Chartier PHONE NO : 781 4579000
32 Wiggins Avenue SE DECISION MADE: 26-DEC-17
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WishBone K-Wire System
WishBone Medical, Inc. 510(k) NO: K173013(Traditional)
ATTN: Gary Barnett PHONE NO : 574 3064006
2150 North Pointe Drive SE DECISION MADE: 14-DEC-17
Warsaw IN 46582 510(k) STATEMENT
DEVICE: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Anhui Kindguard Medical Supplies T510(k) NO: K173017(Traditional)
ATTN: Chen Wei PHONE NO :
Intersection of Yulan Road and ChaSE DECISION MADE: 15-DEC-17
Suzhou CN 234300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CuRAS Nd:YAG Laser
Ilooda Co., Ltd. 510(k) NO: K173038(Traditional)
ATTN: Yun-Jung HA PHONE NO : 720 9625412
120, Jangan-ro 458 Beon-gil JanganSE DECISION MADE: 01-DEC-17
Suwon-Si Gyeonggido KR 16200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Holycon Synthetic Absorbable Sutures
Nantong Holycon Medical Devices Co510(k) NO: K173043(Traditional)
ATTN: Feng Lu PHONE NO : 86 513 80979102
No.66, Zhongyang Road, Economic TeSE DECISION MADE: 14-DEC-17
Nantong CN 226009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P10 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K173058(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 01-DEC-17
Shenzhen CN 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate Anatomic to Reverse Conversion Module
Encore Medical, L.P. 510(k) NO: K173073(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd SE DECISION MADE: 26-DEC-17
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift System (UL400 and UL500)
NeoTract, Inc. 510(k) NO: K173087(Traditional)
ATTN: Louis-Pierre Marcoux PHONE NO : 925 2018861
4473 Willow Road, Suite 100 SE DECISION MADE: 28-DEC-17
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boundary Anterior Lumbar Buttress Plate
Nvision Biomedical Technologies, L510(k) NO: K173091(Traditional)
ATTN: Diana L. Langham PHONE NO : 210 5453713
1350 N Loop 1604 E, Suite 103 SE DECISION MADE: 06-DEC-17
San Antonio TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC 510(k) NO: K173102(Special)
ATTN: Bret M. Berry PHONE NO : 801 2953280
545 West 500 South Suite 100 SE DECISION MADE: 29-DEC-17
Bountiful UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
Globus Medical Inc. 510(k) NO: K173115(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 20-DEC-17
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® VersaTie™ System
NuVasive, Inc. 510(k) NO: K173117(Traditional)
ATTN: Marysa Loustalot PHONE NO : 858 3204549
7475 Lusk Blvd SE DECISION MADE: 07-DEC-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEEK Biosolution
Merz Dental GmbH 510(k) NO: K173124(Traditional)
ATTN: Claudia Bobrowski PHONE NO : 011 43 81403411
Eetzweg 20 SE DECISION MADE: 18-DEC-17
Lutjenburg DE D-24321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 STRATOSPHERE™ Expandable Corpectomy System
Medtronic Sofamor Danek 510(k) NO: K173125(Traditional)
ATTN: Kanesha Hines PHONE NO : 901 3992670
1800 Pyramid Place SE DECISION MADE: 20-DEC-17
Memphis TX 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arisstos™ Spinal System
Ingenium Spine 510(k) NO: K173126(Traditional)
ATTN: David Brumfield PHONE NO : 888 6847861
3145 E. Chandler Blvd. #110 SE DECISION MADE: 05-DEC-17
Phoenix AZ 85048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K173129(Special)
ATTN: Lance Justice PHONE NO : 949 5446540
101 Enterprise, Suite 100 SE DECISION MADE: 01-DEC-17
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reform® Midline Cortical Screw System
Precision Spine, Inc. 510(k) NO: K173130(Traditional)
ATTN: Michael C. Dawson PHONE NO : 601 4204244
2050 Executive Drive SE DECISION MADE: 19-DEC-17
Pearl MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rexious Spinal Fixation System
Huvexel Co., Ltd 510(k) NO: K173131(Special)
ATTN: Sung Hee-Lee PHONE NO : 82 31 7763690
101-105 Megacenter, SK Technopark,SE DECISION MADE: 08-DEC-17
Seongnam-si KR 13207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Hartalega Sdn. Bhd. 510(k) NO: K173137(Traditional)
ATTN: Kuan Kam Hon PHONE NO : 603 62 771733
Dataran Sd Pju 9 SE DECISION MADE: 12-DEC-17
Bandar Sri Damansara MY 52200 510(k) STATEMENT
DEVICE: ACIF
coLigne, AG 510(k) NO: K173148(Traditional)
ATTN: Robert Lange PHONE NO : 41 43 3438000
Utoquai 43 SE DECISION MADE: 01-DEC-17
Zurich CH CH 8008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
NuVasive, Incorporated 510(k) NO: K173153(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 Lusk Blvd. SE DECISION MADE: 06-DEC-17
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift® Expandable System
Life Spine Inc. 510(k) NO: K173182(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 20-DEC-17
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
Thermo Fisher Scientific 510(k) NO: K173209(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909322 4117
1 Thermo Fisher Way SE DECISION MADE: 01-DEC-17
Oakwood Village OH 440146 510(k) STATEMENT
DEVICE: Solana GBS Assay
Quidel Corporation 510(k) NO: K173250(Traditional)
ATTN: Ronald H. Lollar PHONE NO : 740 5893373
2005 East State Street, Suite 100 SE DECISION MADE: 21-DEC-17
Athens OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumiCoil Platinum Fiducial Marker
Boston Scientific Corporation 510(k) NO: K173251(Traditional)
ATTN: Lindsay Forys PHONE NO : 508 6836317
100 Boston Scientific Way SE DECISION MADE: 19-DEC-17
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System
SeaSpine Orthopedics Corporation 510(k) NO: K173260(Traditional)
ATTN: Gina Flores PHONE NO : 760 2165136
5770 Armada Drive SE DECISION MADE: 04-DEC-17
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Octane aspiration system
Vascular Solutions Inc. 510(k) NO: K173266(Traditional)
ATTN: Becky Astrup PHONE NO : 763 7622601
6464 Sycamore Court North SE DECISION MADE: 01-DEC-17
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MasterLoc Stem: Lateralized Plus
Medacta International SA 510(k) NO: K173267(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 07-DEC-17
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Screw Internal Fixation System
Life Spine Inc. 510(k) NO: K173286(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 14-DEC-17
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elite HV Radial
Galt Medical Corp. 510(k) NO: K173287(Traditional)
ATTN: David Derrick PHONE NO : 972 2715177
2220 Merritt Drive SE DECISION MADE: 21-DEC-17
Garland TX 75087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
Liofilchem s. r. l. 510(k) NO: K173307(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 19-DEC-17
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: OMNI Surgical System
Sight Sciences, Inc. 510(k) NO: K173332(Traditional)
ATTN: Anne-Marie Ripley PHONE NO : 661 6458546
3000 Sand Hill Road Building 3, SuSE DECISION MADE: 21-DEC-17
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Operio
Toul Meditech AB 510(k) NO: K173349(Traditional)
ATTN: Tomas Hansson PHONE NO : 46 21 135000
Tunbytorpsgatan 31 SE DECISION MADE: 20-DEC-17
Vasteras SE 72137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy 510(k) NO: K173354(Third Party - Traditional)
ATTN: Henry Boland PHONE NO : 801 5652300
9450 South State Street SE DECISION MADE: 15-DEC-17
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K173369(Traditional)
ATTN: Jean Lei PHONE NO : 86 0755 81885082
Mindray Building, Keji 12th Road SSE DECISION MADE: 13-DEC-17
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSV BellaTek Encode Healing Abutments
Biomet 3i 510(k) NO: K173374(Traditional)
ATTN: Nichole O’Neil PHONE NO : 1 561 7766700
4555 Riverside Drive SE DECISION MADE: 13-DEC-17
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anterior Cervical Plate System
Evolution Spine, LLC 510(k) NO: K173375(Traditional)
ATTN: Douglas Davis PHONE NO : 469 6086582
2300 N. Haskell SE DECISION MADE: 21-DEC-17
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure-Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K173392(Special)
ATTN: Hagit Ephrath PHONE NO : 1 561 3059029
22 Keren Ha'yesod St. SE DECISION MADE: 12-DEC-17
Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Premier 5000
Instrumentation Laboratory Co. 510(k) NO: K173403(Traditional)
ATTN: Carol Marble PHONE NO : 781 8614467
180 Hartwell Road SE DECISION MADE: 29-DEC-17
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radiomics App v1.0
Microsoft Corp. 510(k) NO: K173420(Traditional)
ATTN: Ivan Tarapov PHONE NO : 425 5907761
1 Microsoft Way SE DECISION MADE: 27-DEC-17
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
JVC KENWOOD Corporation 510(k) NO: K173434(Traditional)
ATTN: Masafumi Yugami PHONE NO : 81 258 246611
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 14-DEC-17
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neurosoft TMS (also CloudTMS)
TeleEMG, LLC 510(k) NO: K173441(Special)
ATTN: Joe F. Jabre PHONE NO : 617 8403253
27 Arlington Rd., Building 2, UnitSE DECISION MADE: 13-DEC-17
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Orthofix Srl 510(k) NO: K173458(Special)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via Delle Nazioni 9 SE DECISION MADE: 07-DEC-17
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Pain Relieve Device Model: LT5018C
Shenzhen Dongdixin Technology Co.,510(k) NO: K173462(Special)
ATTN: Siping Yuan PHONE NO : 0086 755 27652471
No. 3 Building Xilibaimang XushengSE DECISION MADE: 08-DEC-17
Shenzhen CN 51808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Diffusion Analysis (ADA) application
Philips Medical Systems Nederland 510(k) NO: K173467(Traditional)
ATTN: Yoram Levy PHONE NO : 1 800 7229377
Veenpluis 4-6 5684 PC Best SE DECISION MADE: 12-DEC-17
Best Noord-Brabant NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
Inari Medical 510(k) NO: K173470(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 04-DEC-17
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Merge PACS
Merge Healthcare Incorporated 510(k) NO: K173475(Traditional)
ATTN: Carol Nakagawa PHONE NO : 905 3648027
900 Walnut Ridge Drive SE DECISION MADE: 08-DEC-17
Hartland WI 53029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crystalsert Lens Delivery System
Bausch & Lomb, Inc 510(k) NO: K173480(Special)
ATTN: Gary Rauvola PHONE NO : 636 2263402
3365 Tree Ct. Industrial Blvd. SE DECISION MADE: 11-DEC-17
St. Louis MO 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorticaLINK Spinal Fusion Platform
LinkSPINE Inc 510(k) NO: K173484(Special)
ATTN: Nickolas Kriska PHONE NO : 410 7725465
5950 Symphony Woods Road, Suite 62SE DECISION MADE: 11-DEC-17
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
MolecularMD Corporation 510(k) NO: K173492(Traditional)
ATTN: Kevin Hawkins PHONE NO : 877 4594979
1341 SW Custer Drive SE DECISION MADE: 22-DEC-17
Portland OR 97219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Alere Scarborough, Inc. 510(k) NO: K173502(Special)
ATTN: Benjamin Crystal PHONE NO : 207 7305820
10 Southgate Road SE DECISION MADE: 13-DEC-17
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAX 5.5™ Spinal System
U&I Corporation 510(k) NO: K173524(Special)
ATTN: Jee Ae Bang PHONE NO : 82 31 8606846
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 13-DEC-17
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Raider Guidewire
Vascular Solutions, Inc. 510(k) NO: K173532(Third Party - Traditional)
ATTN: Beka Vite PHONE NO : 763 6575732
6464 Sycamore Court North SE DECISION MADE: 15-DEC-17
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: T2Candida 1.1 Panel
T2 Biosystems, Inc. 510(k) NO: K173536(Special)
ATTN: Anne Marie Whalen PHONE NO : 781 7614647
101 Hartwell Avenue SE DECISION MADE: 12-DEC-17
Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Alcon Laboratories, Inc. 510(k) NO: K173538(Special)
ATTN: Katryna Warren PHONE NO : 817 6155076
6201 South Freeway SE DECISION MADE: 04-DEC-17
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akros FibuLink™ Syndesmosis Repair Kit
Akros Medical 510(k) NO: K173550(Special)
ATTN: Charles Horrell PHONE NO : 248 2595535
3503 Pleasant Green Rd SE DECISION MADE: 14-DEC-17
Durham NC 27705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E10
GE Healthcare 510(k) NO: K173555(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
9900 Innovation Drive SE DECISION MADE: 20-DEC-17
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph mCT Family of PET/CT Systems
Siemens Medical Solutions USA, Inc510(k) NO: K173578(Special)
ATTN: Tabitha Estes PHONE NO : 865 2182421
810 Innovation Drive SE DECISION MADE: 20-DEC-17
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Amira
Siemens Medical Solutions USA, Inc510(k) NO: K173600(Special)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 19-DEC-17
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima XR646 HD
GE Hualun Medical Systems Co., Ltd510(k) NO: K173612(Special)
ATTN: Kenny Ma PHONE NO : 0086 10 57388715
No.1 Yong Chang North Road, EconomSE DECISION MADE: 11-DEC-17
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K173618(Special)
ATTN: HyunJung Lee PHONE NO : 425 2815061
685 East Middlefield Road SE DECISION MADE: 19-DEC-17
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advocate PTA Catheter
Merit Medical Systems Inc. 510(k) NO: K173621(Traditional)
ATTN: Mark Mullaney PHONE NO : 353 91 703700 3061
Parkmore Business Park West SE DECISION MADE: 13-DEC-17
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FS Ergo
PaloDEx Group Oy 510(k) NO: K173646(Traditional)
ATTN: Anni Lundholm PHONE NO : 358 10 2702000
Nahkelantie 160 SE DECISION MADE: 19-DEC-17
Tuusula FI 04300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Piccolo Composite Nailing System
CarboFix Orthopedics Ltd. 510(k) NO: K173652(Special)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 28-DEC-17
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: speX Support Catheter
ReFlow Medical, Inc. 510(k) NO: K173662(Special)
ATTN: Rebecca K Pine PHONE NO : 760 2905178
1003 Calle Sombra SE DECISION MADE: 20-DEC-17
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic O-arm O2 Imaging System
Medtronic Inc. 510(k) NO: K173664(Special)
ATTN: Dean Honkonen PHONE NO : 978 6986065
300 Foster St SE DECISION MADE: 29-DEC-17
Littleton MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peel-Away Introducer Set
Cook Incorporated 510(k) NO: K173685(Special)
ATTN: Colin Jacob PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489 SE DECISION MADE: 20-DEC-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strange Bile Duct Stone Exploration Set
Cook Incorporated 510(k) NO: K173687(Traditional)
ATTN: Colin Jacob PHONE NO : 812 3353575 104965
750 Daniels Way, P.O. Box 489 SE DECISION MADE: 15-DEC-17
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBL-ABI System
LD Technology LLC 510(k) NO: K173696(Special)
ATTN: Albert Maarek PHONE NO : 305 3799900
100 N. Biscayne Blvd Suite 502 SE DECISION MADE: 19-DEC-17
Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 12
=0.12>=1>
