FDA 510(k) Premarket Notification K963367: RMS K-WIRE

SELENIUM MEDICAL S.A.S. Registration: 1000461041 View Registration

Paragon Medical Inc. Registration: 1000517406 View Registration

Linvatec Corporation Registration: 1017294 View Registration

Sterigenics U.S., LLC Registration: 1018470 View Registration

SMITH & NEPHEW, INC. Registration: 1020279 View Registration

BIOMET MICROFIXATION Registration: 1032347 View Registration

WRIGHT MEDICAL TECHNOLOGY, INC. Registration: 1043534 View Registration

ONYX MEDICAL LLC Registration: 1043653 View Registration

STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration

Sterigenics U.S. LLC Registration: 1054811 View Registration

Sterigenics US LLC Registration: 1058584 View Registration

INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration

BIOACCESS, INC. Registration: 1124621 View Registration

ARTHREX, INC. Registration: 1220246 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration

SYMMETRY MEDICAL, INC. - MANCHESTER Registration: 1221053 View Registration

DePuy Mitek, Inc. Registration: 1221934 View Registration

GEOTEC, INC. Registration: 1222773 View Registration

TESCO ASSOCIATES, INC. Registration: 1226183 View Registration

Tegra Medical - Franklin, MA Registration: 1226191 View Registration

MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration

CONMED CORPORATION Registration: 1320894 View Registration

Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration

Sterigenics US LLC Registration: 1423662 View Registration

Isomedix Operations, Inc. Registration: 1424263 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

SMITH & NEPHEW INC. Registration: 1643264 View Registration

TORNIER, INC. Registration: 1649390 View Registration

Sterigenics US LLC Registration: 1649518 View Registration

SONTEC INSTRUMENTS, INC. Registration: 1720747 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration

DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration

ZIMMER, INC. Registration: 1822565 View Registration

FORT WAYNE METALS RESEARCH PRODUCTS, LLC Registration: 1824313 View Registration

BIOMET, INC. Registration: 1825034 View Registration

ORCHID UNIQUE Registration: 1828288 View Registration

SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration

BIOPRO, INC. Registration: 1833506 View Registration

INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration

PRECISION EDGE SURGICAL PRODUCTS COMPANY Registration: 1833986 View Registration

PARAGON MEDICAL, INC. Registration: 1834331 View Registration

MAITLAND ENGINEERING Registration: 1835572 View Registration

Paragon Medical Inc. Registration: 1835831 View Registration

C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration

MICROAIRE SURGICAL INSTRUMENTS LLC Registration: 2020601 View Registration

Brasseler U.S.A. Medical, LLC Registration: 2025102 View Registration

Viant Upland, Inc Registration: 2027487 View Registration

EAGLE MEDICAL PACKAGING STERILIZATION, INC. Registration: 2028632 View Registration

Sterigenics U.S., LLC Registration: 2029275 View Registration

TRIMED, INC. Registration: 2031009 View Registration

LIFE SCIENCE OUTSOURCING, INC. Registration: 2031093 View Registration

Isomedix Operations, Inc Registration: 2032098 View Registration

ORTHOFIX US LLC Registration: 2183449 View Registration

Key Surgical, LLC Registration: 2183785 View Registration

RMS CO. Registration: 2183946 View Registration

Spectrum Plastics Group Registration: 2183967 View Registration

IMPLANT RESOURCE, INC. Registration: 2184171 View Registration

LYNX Medical NJ Registration: 2244478 View Registration

ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration

GSOURCE, LLC. Registration: 2249529 View Registration

SCT, INC. Registration: 2249615 View Registration

Sklar Corporation Registration: 2431166 View Registration

A.M. SURGICAL, INC. Registration: 2437731 View Registration

DSM Biomedical, Inc. Registration: 2530154 View Registration

STRYKER PUERTO RICO, LLC. Registration: 2648666 View Registration

STRYKER ENDOSCOPY Registration: 2936485 View Registration

Synthes GMBH Registration: 3000270450 View Registration

LINEMASTER SWITCH CORP. Registration: 3001592626 View Registration

Arthrex GmbH Registration: 3002579136 View Registration

STERIS SPA Registration: 3002806470 View Registration

IONISOS Registration: 3002807295 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration

SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration

Sterigenics US LLC Registration: 3002907620 View Registration

MERETE GMBH Registration: 3002949614 View Registration

MEDARTIS AG Registration: 3003236702 View Registration

Integra LifeSciences Corporation Registration: 3003418325 View Registration

QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration

SMITH & NEPHEW INC. Registration: 3003604053 View Registration

FARMACO QUIMICA NACIONAL, S.A. Registration: 3003755939 View Registration

MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration

DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration

C&W SWISS, INC. Registration: 3004635447 View Registration

PURACON GMBH Registration: 3004638532 View Registration

SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration

SPINAL ELEMENTS, INC. Registration: 3004893332 View Registration

DONATELLE PLASTICS, LLC Registration: 3004961578 View Registration

TORNIER Inc. Registration: 3004983210 View Registration

Graham Medical Technologies, L.L.C. d.b.a. GraMedica Registration: 3004993707 View Registration

SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration

MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration

Bioretec Ltd. Registration: 3005536892 View Registration

BGS Beta-Gamma-Service GmbH & Co KG Registration: 3005562917 View Registration

PACIFIC INSTRUMENTS INC. Registration: 3005641619 View Registration

Jarit GmbH Registration: 3005809810 View Registration

RUETSCHI TECHNOLOGY AG Registration: 3005827567 View Registration

BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration

HG Medical GmbH Registration: 3006272282 View Registration

CANWELL MEDICAL CO., LTD. Registration: 3006395932 View Registration

ORTHOPEDIATRICS, CORP Registration: 3006460162 View Registration

INNOMED, S.A. DE C.V. Registration: 3006498370 View Registration

GPC MEDICAL LIMITED Registration: 3006513362 View Registration

ArthroCare Corporation Registration: 3006524618 View Registration

ETHICON, INC. Registration: 3006638824 View Registration

CREATEC GmbH & CO. KG Registration: 3006694268 View Registration

SKELETAL DYNAMICS, INC Registration: 3006742481 View Registration

STRUCTURE MEDICAL, LLC. Registration: 3006783837 View Registration

Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration

BIOMET FRANCE Registration: 3006946279 View Registration

Surgical Specialties Corporation Limited (UK) Registration: 3007109793 View Registration

Apex (Guangzhou) Tools & Orthopedics Company Registration: 3007125392 View Registration

STARR FRAME LLC Registration: 3007130914 View Registration

Smith & Nephew, Inc. Registration: 3007366790 View Registration

Trilliant Surgical LLC Registration: 3007420745 View Registration

Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration

Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration

Structure Medical, LLC. Registration: 3007993775 View Registration

Limacorporate S.p.A. Registration: 3008021110 View Registration

Synergy Health Radeberg GMBH Registration: 3008102042 View Registration

MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

RIVERSIDE MEDICAL PACKAGING COMPANY LTD Registration: 3008559295 View Registration

PARAGON 28 Registration: 3008650117 View Registration

MEDIPLAST ISRAEL LTD Registration: 3008729892 View Registration

Smith & Nephew, Inc. Registration: 3008744062 View Registration

SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD. Registration: 3008749819 View Registration

SAMAPLAST AG Registration: 3008793310 View Registration

Swann-Morton(Services) Limited Registration: 3008812251 View Registration

Synthes (USA) Products LLC Registration: 3008812560 View Registration

ARROWHEAD DE LLC Registration: 3008817603 View Registration

EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration

Ortho Solutions UK Limited Registration: 3008951116 View Registration

Z-MEDICAL GMBH & CO. KG Registration: 3009110133 View Registration

AMETEK Poland sp. z o.o. Registration: 3009141957 View Registration

4WEB INC. Registration: 3009189869 View Registration

LEITNER AG Registration: 3009381600 View Registration

SYNTHES GMBH Registration: 3009417901 View Registration

Arthrex Logistic Center Registration: 3009423112 View Registration

HNM Medical dba HNM TOTAL RECON Registration: 3009513193 View Registration

Medartis Inc. Registration: 3009540749 View Registration

CG MedTech USA, Inc. Registration: 3009554293 View Registration

RED STAR CONTRACT MANUFACTURING INC. Registration: 3009631939 View Registration

BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration

METRIC MEDICAL DEVICES, INC. Registration: 3009746186 View Registration

MEDICAL DEVICE AND IMPLANTS LLC Registration: 3009826895 View Registration

ARCH Medical Solutions - Warsaw Registration: 3009971621 View Registration

Engineered Medical Systems, LLC Registration: 3009973336 View Registration

ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration

B & J Medical LLC Registration: 3009973699 View Registration

Tegra Medical Registration: 3010041499 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

Synergy Health Sterilisation UK Ltd Registration: 3010155648 View Registration

Synergy Health Marseille SAS Registration: 3010162973 View Registration

Synergy Health Westport Ltd Registration: 3010173425 View Registration

IONISOS Registration: 3010178296 View Registration

IONISOS Pouzauges Registration: 3010329663 View Registration

Arthrex, Inc. Registration: 3010331645 View Registration

FMI MEDISCH BV Registration: 3010370500 View Registration

STERISERVICES Registration: 3010383847 View Registration

MEDICATECHNOLOGIE Registration: 3010389204 View Registration

TRIBE MEDICAL GROUP Registration: 3010400367 View Registration

SIMAGEC Registration: 3010462278 View Registration

In2Bones SAS Registration: 3010470577 View Registration

WRIGHT MEDICAL TECHNOLOGY, INC. Registration: 3010667733 View Registration

NOVASTEP Registration: 3010673777 View Registration

MK medical GmbH Registration: 3010673850 View Registration

AXIAL MEDICAL Registration: 3010863450 View Registration

4WEB EU B.V. Registration: 3011127597 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

Arthrex Mexico, S.A. de C.V. Registration: 3011230048 View Registration

NVISION BIOMEDICAL TECHNOLOGIES, INC Registration: 3011301313 View Registration

EPTAM WEST LLC Registration: 3011302692 View Registration

SPITREX ORTHOPEDICS SWITZERLAND SA Registration: 3011500362 View Registration

IN2BONES USA, LLC Registration: 3011580264 View Registration

OsteoCentric Technologies,Inc Registration: 3011656326 View Registration

Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration

MEDICAL COMPONENT SPECIALISTS Registration: 3011874600 View Registration

Stryker Endoscopy Registration: 3012103978 View Registration

ORTOSISTEMAS, S.A. Registration: 3012329552 View Registration

Arthrocare Corporation Registration: 3012358417 View Registration

SANICURE BV Registration: 3012494290 View Registration

Ortho Solutions Sdn Bhd Registration: 3012755988 View Registration

SPINAL RESOURCES INC Registration: 3012770122 View Registration

Device Innovation Company Limited Registration: 3012818475 View Registration

CROSMED S.A. Registration: 3012883081 View Registration

Tyber Medical Registration: 3012966183 View Registration

MAHE MEDICAL USA Registration: 3013011598 View Registration

Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration

ZIMMER PTE. LTD. Registration: 3013176080 View Registration

ARVATO Netherlands B.V. Registration: 3013302242 View Registration

FUSION ORTHOPEDICS USA, LLC Registration: 3013365802 View Registration

DIAMOND ORTHOPEDIC Registration: 3013540005 View Registration

WISHBONE MEDICAL INC. Registration: 3013680140 View Registration

Arthrex Korea Ltd. Registration: 3013700547 View Registration

Arthrex Singapore Pte Ltd. Registration: 3014004349 View Registration

Maestro Logistics, LLC Registration: 3014129047 View Registration

3D INSTRUMENTATION SDN BHD Registration: 3014170143 View Registration

C&A Tool Engineering, Inc. Auburn Plant Registration: 3014252644 View Registration

Arthrex (Shanghai) Co., Ltd. Registration: 3014262693 View Registration

BIOMET CHILE S.A. Registration: 3014302784 View Registration

Aristotech Industries GmbH Registration: 3014314623 View Registration

Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration

Suzhou Ahno Medical Devices Co., Ltd. Registration: 3014315669 View Registration

QUADM TECHNOLOGIES, LLC Registration: 3014527928 View Registration

OSSIO LTD. Registration: 3014554088 View Registration

ABLE MEDICAL DEVICES Registration: 3014680795 View Registration

restor3d, inc. Registration: 3014833750 View Registration

FIELD ORTHOPAEDICS Registration: 3015131017 View Registration

BOULDER BIOMED LLC Registration: 3015151147 View Registration

Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration

Jabil Inc. (Brandywine) Registration: 3015212339 View Registration

Arthrex Manufacturing Inc. Registration: 3015231789 View Registration

Jabil Inc. (Monument) Registration: 3015399803 View Registration

Jabil Inc. (Elmira) Registration: 3015440604 View Registration

CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration

JOINSMART BIOMEDICAL CO., LTD. Registration: 3015539532 View Registration

Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration

ARCTIC BIOMATERIALS OY Registration: 3015780293 View Registration

I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration

Sklar Corporation - Warehouse Registration: 3015895045 View Registration

ORTHONOVIS, INC. Registration: 3015946784 View Registration

Stryker Instruments Registration: 3015967359 View Registration

Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda Registration: 3015974593 View Registration

MAINSTREAM MEDICAL DEVICES Registration: 3016112537 View Registration

ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration

TESLAKE, INC. Registration: 3016496998 View Registration

VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY Registration: 3016727307 View Registration

Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration

KINGJ MEDICAL CO., LTD Registration: 3017191784 View Registration

RIWOSPINE GMBH Registration: 3017406274 View Registration

Tyber Medical Registration: 3017980495 View Registration

Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration

INTELIVATION TECHNOLOGIES, LLC Registration: 3019356409 View Registration

ORTHO-MED, INC. Registration: 3019455 View Registration

Arthrex New Zealand Limited Registration: 3020704423 View Registration

ARMIS BIOPHARMA, INC. Registration: 3020745223 View Registration

Transmedic Philippines Inc. Registration: 3020899789 View Registration

ARVATO USA LLC Registration: 3021008900 View Registration

Arthrex Colombia SAS Registration: 3021226419 View Registration

BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration

BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration

Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration

SURGICAL FUSION INC. Registration: 3022472578 View Registration

SURGICAL FUSION TECHNOLOGIES GmbH Registration: 3022518322 View Registration

Hipp Medical AG Registration: 3023852420 View Registration

ACUMED LLC Registration: 3025141 View Registration

SIMPEX MEDICAL, INC. Registration: 3025266 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration

TOETAL SOLUTIONS, INC Registration: 3026032087 View Registration

BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration

Arthrex Chile SPA Registration: 3027339877 View Registration

CATHTEK LLC Registration: 3027553380 View Registration

MIING WEI CO., LTD. Registration: 3030183061 View Registration

MEDIWORX.ONE GMBH Registration: 3030655570 View Registration

MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration

DePuy Synthes Sales Registration: 3034676720 View Registration

Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration

Smith & Nephew, Inc. Registration: 3038503932 View Registration

Stryker Ireland Ltd. Instruments Division, Innovation Centre Registration: 3040335671 View Registration

APLUS (GUANGZHOU) MEDICAL TECHNOLOGY COMPANY Registration: 3042285592 View Registration

MEDULOC Registration: 3042903229 View Registration

STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration

GEBR. BRASSELER GMBH & CO. KG Registration: 8010468 View Registration

SYNTHES GMBH / Synthes Produktions GmbH Registration: 8030965 View Registration

STRYKER GmbH Registration: 8031020 View Registration

STERIS Schweiz AG Registration: 8043792 View Registration

AAP IMPLANTATE AG Registration: 8043862 View Registration

STRYKER TRAUMA GMBH Registration: 9610622 View Registration

RUDOLF STORZ GMBH Registration: 9611274 View Registration

SMITH & NEPHEW ORTHOPAEDICS AG Registration: 9613369 View Registration

NARANG MEDICAL, LTD. Registration: 9613910 View Registration

VCN TECHNOLOGIES Registration: 9615765 View Registration

STRYKER IRELAND LTD., INSTRUMENTS DIVISION Registration: 9616696 View Registration

SYNTEC SCIENTIFIC CORP. Registration: 9616944 View Registration

CG MedTech Co., Ltd. Registration: 9617297 View Registration

SMT SCHILLING METALLTECHNIK GMBH Registration: 9680619 View Registration

ORTHOFIX SRL Registration: 9680825 View Registration

Gammatom S.r.l. Registration: 9681465 View Registration

INION OY Registration: 9710629 View Registration

RMS K-WIRE

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