FDA 510(k) Premarket Notification K213209: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

Linvatec Corporation Registration: 1017294 View Registration

MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration

BIOMET MICROFIXATION Registration: 1032347 View Registration

ONYX MEDICAL LLC Registration: 1043653 View Registration

STERIMED, Inc. Registration: 1053306 View Registration

ENVIROPAK LLC Registration: 1056276 View Registration

BOSS INSTRUMENTS, LTD. Registration: 1056350 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 View Registration

GRACE MEDICAL, INC. Registration: 1057421 View Registration

EBNER MEDICAL LLC Registration: 1058020 View Registration

Sterigenics US LLC Registration: 1058584 View Registration

SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) Registration: 1062741 View Registration

SMITH & NEPHEW INC. Registration: 1219602 View Registration

Covidien Registration: 1219930 View Registration

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

ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration

DePuy Mitek, Inc. Registration: 1221934 View Registration

HOLOGIC, INC. Registration: 1222780 View Registration

Microline Surgical, Inc Registration: 1223422 View Registration

Vericel Corporation Registration: 1226230 View Registration

SunMed Group Holdings, LLC Registration: 1314417 View Registration

Crosstex International Registration: 1319130 View Registration

CONMED CORPORATION Registration: 1320894 View Registration

BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration

MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration

AMCOR FLEXIBLES, LLC Registration: 1418005 View Registration

RICHARD WOLF MEDICAL INSTRUMENTS CORP. Registration: 1418479 View Registration

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

PHOENIX INSTRUMENTS, INC. Registration: 1421879 View Registration

Sterigenics US LLC Registration: 1423662 View Registration

THOMPSON SURGICAL INSTRUMENTS, INC. Registration: 1450428 View Registration

STERIS Corporation Registration: 1526531 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

Covidien Registration: 1717344 View Registration

MicroCare Medical Registration: 1720499 View Registration

MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration

ORCHID UNIQUE Registration: 1828288 View Registration

SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration

Viant AS&O Holdings, LLC Registration: 1832228 View Registration

INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration

PARAGON MEDICAL, INC. Registration: 1834331 View Registration

MICROPULSE INC Registration: 1834379 View Registration

NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration

Avalign Delivery Systems Division Registration: 1835444 View Registration

ASPEN SURGICAL PRODUCTS, INC. Registration: 1836161 View Registration

STERIS Corporation Registration: 1923569 View Registration

JEDMED Instrument Company Registration: 1926681 View Registration

SURGICAL INSTRUMENT MANUFACTURERS, LLC Registration: 1935627 View Registration

YOUNG DENTAL MANUFACTURING CO 1, LLC. Registration: 1941138 View Registration

BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration

KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration

MICROAIRE SURGICAL INSTRUMENTS LLC Registration: 2020601 View Registration

Amcor Flexibles, Commerce Registration: 2023811 View Registration

Kerr Corporation Registration: 2024312 View Registration

ALPHATEC SPINE, INC. Registration: 2027467 View Registration

OSTEOMED Registration: 2027754 View Registration

NUVASIVE, INC. Registration: 2031966 View Registration

PRO-DEX, INC. Registration: 2081135 View Registration

ADVANCED STERILIZATION PRODUCTS Registration: 2084725 View Registration

STOLL METALCRAFT, INC. Registration: 2087234 View Registration

TECOMET, INC. Registration: 2132732 View Registration

LOWELL,INC. Registration: 2134470 View Registration

PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration

CASE MEDICAL, INC. Registration: 2248608 View Registration

GSOURCE, LLC. Registration: 2249529 View Registration

FLEXBAR MACHINE CORP. Registration: 2424366 View Registration

Sklar Corporation Registration: 2431166 View Registration

ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. Registration: 2434839 View Registration

DUKAL LLC Registration: 2435946 View Registration

ORTHOPLI CORP. Registration: 2518634 View Registration

AESCULAP, INC. Registration: 2916714 View Registration

HAND BIOMECHANICS LAB, INC. Registration: 2919128 View Registration

STRYKER ENDOSCOPY Registration: 2936485 View Registration

Synthes GMBH Registration: 3000270450 View Registration

SWEDEN & MARTINA S.P.A. Registration: 3001082453 View Registration

IMPLANT DIRECT SYBRON MANUFACTURING LLC Registration: 3001617766 View Registration

INTUITIVE SURGICAL, INC. Registration: 3001675293 View Registration

HUPFER METALLWERKE GMBH & CO. KG Registration: 3002259632 View Registration

USTOMED INSTRUMENTE GMBH & CO. KG Registration: 3002808270 View Registration

MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration

AR MEDICOM INC., (ASIA), LTD. Registration: 3003230618 View Registration

MEDARTIS AG Registration: 3003236702 View Registration

SOUTHERN IMPLANTS (PTY) LTD Registration: 3003394627 View Registration

Integra LifeSciences Corporation Registration: 3003418325 View Registration

QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration

SMITH & NEPHEW INC. Registration: 3003604053 View Registration

GYRUS ACMI, INC. Registration: 3003790304 View Registration

MACKAY MANUFACTURING, INC. Registration: 3003935342 View Registration

CALDERA MEDICAL, INC. Registration: 3003990090 View Registration

STERIS CORPORATION Registration: 3004080920 View Registration

JEWEL PRECISION SHEET METAL & MACHINING, INC. Registration: 3004112448 View Registration

ConforMIS, Inc. Registration: 3004153240 View Registration

HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC Registration: 3004193466 View Registration

S.I.N. Implant System Ltda Registration: 3004201263 View Registration

MIS Implants Technologies Ltd. Registration: 3004203816 View Registration

MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration

DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration

ConMed Corporation Registration: 3004491689 View Registration

INTEGRA LIFESCIENCES CORPORATION Registration: 3004608878 View Registration

Viant Medical, LLC Registration: 3004976965 View Registration

RAM PRECISION INDUSTRIES INC Registration: 3005004799 View Registration

Ermis MedTech Registration: 3005071827 View Registration

JOIMAX GMBH Registration: 3005083075 View Registration

Mectron North America Registration: 3005282635 View Registration

MEDICAL CONTENEUR SAS Registration: 3005360851 View Registration

PARAGON IMPLANT MFG., LLC Registration: 3005409899 View Registration

MICRO PRECISION SWISS Registration: 3005497913 View Registration

RE:BUILD TEKNA, LLC Registration: 3005694091 View Registration

TURNER MEDICAL INC. Registration: 3005706667 View Registration

BAHADIR USA LLC Registration: 3005741909 View Registration

COCHLEAR AMERICAS Registration: 3005900820 View Registration

CROSSTEX INTERNATIONAL, INC. Registration: 3006008984 View Registration

AYGUN SURGICAL INSTRUMENTS CO.,INC. Registration: 3006113180 View Registration

NuVasive Specialized Orthopedics, Inc. Registration: 3006179046 View Registration

NOBEL BIOCARE DISTRIBUTION CENTER BV Registration: 3006540014 View Registration

STERIS Deutschland GmBh Registration: 3006554912 View Registration

Hoogland Spine Products GmbH Registration: 3006561161 View Registration

SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD Registration: 3006639944 View Registration

SKELETAL DYNAMICS, INC Registration: 3006742481 View Registration

STRUCTURE MEDICAL, LLC. Registration: 3006783837 View Registration

INKUTEC GMBH Registration: 3006846433 View Registration

Z-SYSTEMS AG Registration: 3006948427 View Registration

Oticon Medical AB Registration: 3007367732 View Registration

Algram Group Ltd Registration: 3007389669 View Registration

ContainMed, Inc. Registration: 3007695749 View Registration

MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration

Medicom Asia-Pacific Holdings Limited. Taiwan Branch Registration: 3008132392 View Registration

OM HEALTHCARE LOGISTICS OM03 Registration: 3008135745 View Registration

BEGO IMPLANT SYSTEMS GMBH & CO. KG Registration: 3008252251 View Registration

JJGC Industria e Comercio de Materiais Dentarios SA Registration: 3008261720 View Registration

TALLADIUM ESPANA, SL Registration: 3008517893 View Registration

SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration

Nobel Biocare Services AG Registration: 3008693672 View Registration

SUMMIT MEDICAL LLC Registration: 3008719017 View Registration

NOVO SURGICAL, INC. Registration: 3008770252 View Registration

AVINENT IMPLANT SYSTEM S.L.U. Registration: 3008791019 View Registration

Synthes (USA) Products LLC Registration: 3008812560 View Registration

STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration

AVALIGN TECHNOLOGIES, Inc. Registration: 3008864603 View Registration

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

Lianyungang Anson Non-woven Product Co., Ltd. Registration: 3008959420 View Registration

INSERT MOLDING SOLUTIONS, INC. Registration: 3009050824 View Registration

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

Demant Operations Poland Sp. z o.o. Registration: 3009307953 View Registration

SYNTHES GMBH Registration: 3009417901 View Registration

HNM Medical dba HNM TOTAL RECON Registration: 3009513193 View Registration

Medicraft Inc Registration: 3009538923 View Registration

FABTECH PRECISION SHEET METAL, LLC Registration: 3009539885 View Registration

Medartis Inc. Registration: 3009540749 View Registration

Ferry Machine Corporation Registration: 3009959868 View Registration

HU-FRIEDY MFG CO., LLC Registration: 3009968482 View Registration

ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration

J&B PRECISION, INC. Registration: 3010041430 View Registration

Teleflex LLC (NADC) Registration: 3010041511 View Registration

LH MEDICAL CORPORATION Registration: 3010057495 View Registration

FLEX-CELL PRECISION, INC. Registration: 3010120135 View Registration

R.H. CROSS ENTERPRISES, INC. Registration: 3010141593 View Registration

Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration

EIKON DEVICE INC. Registration: 3010363542 View Registration

RINGELE AG Registration: 3010393565 View Registration

FETZER SURGICAL, LLC Registration: 3010687973 View Registration

KARL STORZ SE & CO. KG Registration: 3010707607 View Registration

INNOVATIVE STERILIZATION TECHN Registration: 3010772758 View Registration

Gyrus ACMI, Inc. Registration: 3011050570 View Registration

Teleflex Medical LLC Registration: 3011137372 View Registration

SWEDEN & MARTINA INC Registration: 3011276344 View Registration

MEDIN TECHNOLOGIES, INC. Registration: 3011296511 View Registration

SANTA BARBARA IMAGING SYSTEMS Registration: 3011373951 View Registration

Wipak Packaging (Changshu) co., Ltd. Registration: 3011533888 View Registration

ARGON MEDICAL PRODUCTIONS & VERTRIEBS GESELLSCHAFT MBH & CO. Registration: 3011575197 View Registration

Titan Spine, a Division of Medtronic Registration: 3011577940 View Registration

PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration

MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH Registration: 3011795235 View Registration

DENTSPLY IH BV Registration: 3011824442 View Registration

Gebr. Schwarz GmbH Registration: 3012055599 View Registration

SterCUBE Surgical Systems, LLC Registration: 3012085539 View Registration

Johnson & Johnson Surgical Vision, Inc. Registration: 3012236936 View Registration

KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration

MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration

SANICURE BV Registration: 3012494290 View Registration

Integra Canada ULC Registration: 3012507533 View Registration

Cochlear Malaysia Sdn Bhd Registration: 3013177549 View Registration

ORTA MEDICAL LTD Registration: 3013188547 View Registration

Arvato SE Registration: 3013247477 View Registration

Intuitive Surgical G.K. Registration: 3013283620 View Registration

Humphry's Industrial Products Inc Registration: 3013357025 View Registration

NEO MEDICAL S.A. Registration: 3013546462 View Registration

CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration

NEO SPINE USA INC. Registration: 3014003062 View Registration

TydenBrooks Registration: 3014191428 View Registration

BIOTECH DENTAL SAS Registration: 3014290448 View Registration

Integra LifeSciences Production Corporation Registration: 3014334038 View Registration

KARL STORZ SE & CO KG Registration: 3014342096 View Registration

STERIZIGN PRECISION TECHNOLOGIES Registration: 3014409963 View Registration

O&M Halyard, Inc. Registration: 3014421917 View Registration

MBM PACKAGING LABS, INC Registration: 3014553709 View Registration

Cochlear Americas Warehouse Registration: 3014579188 View Registration

Pacific Hospital Supply Co., Ltd Registration: 3014615028 View Registration

GLW, Inc. Registration: 3014967149 View Registration

NEOTRACT, INC. Registration: 3015181082 View Registration

SUPREME SCREW PRODUCTS Registration: 3015336263 View Registration

ASP Global Manufacturing GmbH Registration: 3015392401 View Registration

ALPHATEC SPINE, INC. Registration: 3015537048 View Registration

INTUITIVE SURGICAL, INC. Registration: 3015612252 View Registration

EGMEDICAL SRL Registration: 3015746537 View Registration

Sklar Corporation - Warehouse Registration: 3015895045 View Registration

ANDERSEN INDUSTRIES CO., LTD. Registration: 3015960676 View Registration

Stryker Instruments Registration: 3015967359 View Registration

ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration

SK PHARMA LOGISTICS GMBH Registration: 3017155536 View Registration

United Medical Enterprise, Inc. Registration: 3017949824 View Registration

Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration

Alphatec Spine, Inc. Registration: 3019878714 View Registration

CROSSROADS EXTREMITY SYSTEMS LLC Registration: 3020584246 View Registration

RP MEDICAL INC. Registration: 3020767943 View Registration

Assembly-Tek LLC Registration: 3021119558 View Registration

Activ Surgical Inc Registration: 3021336392 View Registration

Intuitive Surgical, Inc. Registration: 3022626486 View Registration

MAXMORESPINE Registration: 3023155873 View Registration

Hipp Medical AG Registration: 3023852420 View Registration

Pro-Dex Inc Registration: 3024788684 View Registration

Covidien Registration: 3026612481 View Registration

HOOSIER PLASTICS INC Registration: 3027345187 View Registration

INFINITUM ETA LTD. Registration: 3027665899 View Registration

PARAGON IMPLANT COMPANY, LLC Registration: 3033708818 View Registration

DePuy Synthes Sales Registration: 3034676720 View Registration

Medicom Healthcare (Thailand) Co., Ltd. Registration: 3036622014 View Registration

INFINETAMED AG Registration: 3038549074 View Registration

OKETZ LOGISTICS LLC Registration: 3038718579 View Registration

MURUI INTERNATIONAL CO., LTD Registration: 3043164947 View Registration

ZAPALIGN LLC Registration: 3043226252 View Registration

IDEATE MEDICAL Registration: 3043237009 View Registration

FERRY MACHINE CORPORATION Registration: 3043543260 View Registration

MEDICON, E.G. Registration: 8010099 View Registration

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

GEISTER MEDIZINTECHNIK GMBH Registration: 8010697 View Registration

ANTHOGYR Registration: 8020776 View Registration

Industrias Apson S.A de C.V Registration: 8030607 View Registration

ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V. Registration: 8030674 View Registration

QSA SURGICAL (PVT) LTD. Registration: 8040233 View Registration

STERIS Schweiz AG Registration: 8043792 View Registration

T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 8043971 View Registration

PACIFIC HOSPITAL SUPPLY CO. LTD. Registration: 8044099 View Registration

AESCULAP AG Registration: 9610612 View Registration

KARL STORZ SE & CO. KG Registration: 9610617 View Registration

OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration

RICHARD WOLF GMBH Registration: 9611102 View Registration

RUDOLF STORZ GMBH Registration: 9611274 View Registration

HELMUT ZEPF MEDIZINTECHNIK GMBH Registration: 9611367 View Registration

AMD Medicom Inc. Registration: 9611959 View Registration

NOBEL BIOCARE AB Registration: 9611992 View Registration

GIMMI GMBH Registration: 9612074 View Registration

Dentsply IH AB Registration: 9612468 View Registration

WIPAK OY Registration: 9613277 View Registration

INSTITUT STRAUMANN AG Registration: 9613348 View Registration

Straumann Villeret SA Registration: 9614404 View Registration

COCHLEAR BONE ANCHORED SOLUTIONS AB Registration: 9616024 View Registration

La Ada de Acuna Registration: 9616096 View Registration

SPS Medical Registration: 9617111 View Registration

SOADCO, S.L. Registration: 9617542 View Registration

MEDIPACK MEDICAL PACKAGING MFG. CO. Registration: 9680261 View Registration

RZ MEDIZINTECHNIK GMBH Registration: 9680718 View Registration

HERMANN MUELLER Medizintechnik GmbH Registration: 9680735 View Registration

SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration

Sirona Dental Systems GmbH Registration: 9681851 View Registration

ULTIMATE MEDICAL PRODUCTS LTD. Registration: 9710524 View Registration

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

Submission Details & Decision

Related Establishments / Registrations

Public Record Disclaimer