MALLORY-HEAD TOTAL HIP SYSTEM

• Paragon Medical - Dayton Registration: 1000200989 View Registration
• MEPROTECH Registration: 1000294921 View Registration
• IMPLANTS INTL. LTD. Registration: 1000547811 View Registration
• Himed, LLC Registration: 1000577893 View Registration
• Sterigenics U.S., LLC Registration: 1018470 View Registration
• SMITH & NEPHEW, INC. Registration: 1020279 View Registration
• EXACTECH, INC. Registration: 1038671 View Registration
• ONYX MEDICAL LLC Registration: 1043653 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
• SOUTHEASTERN TECHNOLOGY dba Autocam Medical Registration: 1057425 View Registration
• INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
• ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
• Viant AS&O Holdings, LLC Registration: 1218882 View Registration
• DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
• SYMMETRY MEDICAL, INC. - MANCHESTER Registration: 1221053 View Registration
• ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration
• OMNIlifeScience, Inc. Registration: 1226188 View Registration
• MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 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
• ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
• APS MATERIALS, INC. Registration: 1529009 View Registration
• HAMMILL MFG. CO. Registration: 1530390 View Registration
• NORWOOD MEDICAL LLC Registration: 1531174 View Registration
• SMITH & NEPHEW INC. Registration: 1643264 View Registration
• ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
• ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
• CENTEX MACHINING, INC. Registration: 1645151 View Registration
• Sterigenics US LLC Registration: 1649518 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
• Sterigenics U.S., LLC Registration: 1721676 View Registration
• ORTHO DEVELOPMENT CORP. Registration: 1722511 View Registration
• DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
• ZIMMER, INC. Registration: 1822565 View Registration
• BIOMET, INC. Registration: 1825034 View Registration
• ORCHID ORTHOPEDICS-CHELSEA Registration: 1827096 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
• MICROPULSE INC Registration: 1834379 View Registration
• NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration
• Avalign Delivery Systems Division Registration: 1835444 View Registration
• MAITLAND ENGINEERING Registration: 1835572 View Registration
• Paragon Medical Inc. Registration: 1835831 View Registration
• C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration
• Isomedix Operations, Inc. Registration: 2030624 View Registration
• PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
• Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
• RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
• Isomedix Operations, Inc. Registration: 2183744 View Registration
• KEN-MAR MACHINE MFG CORP Registration: 2242737 View Registration
• LYNX Medical NJ Registration: 2244478 View Registration
• ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
• Isomedix Operations Inc. Registration: 2246552 View Registration
• SCT, INC. Registration: 2249615 View Registration
• HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
• LYNX Medical Pennsylvania Registration: 2528981 View Registration
• ZIMMER MANUFACTURING B.V. Registration: 2648920 View Registration
• Polymer Corporation Registration: 3000196378 View Registration
• MACK MOLDING COMPANY Registration: 3000236920 View Registration
• GB IMPLANTAT TECHNOLOGIE GMBH Registration: 3000258338 View Registration
• ORTHOPLASTICS LTD Registration: 3000264985 View Registration
• CERAMTEC GmbH Medical Products Division Registration: 3001278222 View Registration
• SMITHSTOWN LIGHT ENGINEERING Registration: 3001284227 View Registration
• THEKEN COMPANIES, LLC Registration: 3002498892 View Registration
• STERIS SPA Registration: 3002806470 View Registration
• BIOMET UK LTD. Registration: 3002806535 View Registration
• STERIS SPA Registration: 3002806603 View Registration
• Sterigenics Germany GmbH Registration: 3002807090 View Registration
• GREENPIA TECHNOLOGY INC. Registration: 3002807112 View Registration
• IONISOS Registration: 3002807295 View Registration
• Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
• Synergy Health Ireland Ltd Registration: 3002807314 View Registration
• SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration
• KOGA ISOTOPE LTD. Registration: 3002807408 View Registration
• ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
• Sterigenics US LLC Registration: 3002907620 View Registration
• Phillips Precision Inc Registration: 3003387384 View Registration
• QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
• T & L SHARPENING, INC. Registration: 3003541440 View Registration
• Vaupell Midwest Molding and Tooling Registration: 3003595343 View Registration
• OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
• HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
• SYMMETRY MEDICAL MANUFACTURING INC. Registration: 3003791208 View Registration
• MATERIALISE N.V. Registration: 3003998208 View Registration
• GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
• ConforMIS, Inc. Registration: 3004153240 View Registration
• DONSON MACHINE COMPANY Registration: 3004153896 View Registration
• B & G MFG. CO. Registration: 3004188066 View Registration
• Waldemar Link GmbH & Co. KG Registration: 3004371426 View Registration
• WINDSOR BEACH TECHNOLOGIES, INC. Registration: 3004493876 View Registration
• FIVE STAR MANUFACTURING, INC. Registration: 3004513872 View Registration
• C&W SWISS, INC. Registration: 3004635447 View Registration
• PURACON GMBH Registration: 3004638532 View Registration
• ENZTEC LIMITED Registration: 3004641308 View Registration
• SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration
• SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
• MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration
• XIAN AIRFOIL TECHNOLOGY CO., LTD. Registration: 3005323511 View Registration
• ABBOTT LABORATORIES Registration: 3005333358 View Registration
• MEDICAL CONTENEUR SAS Registration: 3005360851 View Registration
• SMITH & NEPHEW, INC. Registration: 3005551626 View Registration
• BGS Beta-Gamma-Service GmbH & Co KG Registration: 3005562917 View Registration
• Materialise USA, LLC. Registration: 3005718816 View Registration
• Zimmer Trabecular Metal Technology, Inc. Registration: 3005751028 View Registration
• ACCENTUS MEDICAL LTD Registration: 3005913274 View Registration
• DOT GMBH Registration: 3006001176 View Registration
• BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
• Nemcomed FW LLC Registration: 3006128100 View Registration
• JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Registration: 3006356043 View Registration
• CANWELL MEDICAL CO., LTD. Registration: 3006395932 View Registration
• KYOCERA Medical Corporation Shiga Higashiomi Plant Registration: 3006536454 View Registration
• Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration
• Biomet Mexico Registration: 3006809628 View Registration
• MEDISTRI SA Registration: 3006946276 View Registration
• BIOMET FRANCE Registration: 3006946279 View Registration
• MEDICAL GROUP Registration: 3007051929 View Registration
• MEDICOAT SAS Registration: 3007120646 View Registration
• SFERIC Registration: 3007200272 View Registration
• MAXX ORTHOPEDICS INC. Registration: 3007311878 View Registration
• CPM Medical Consultants, LLC. Registration: 3007334927 View Registration
• LINCOTEK TRENTO S.P.A Registration: 3007353762 View Registration
• Smith & Nephew, Inc. Registration: 3007366790 View Registration
• GRUPPO BIOIMPIANTI S.R.L. Registration: 3007391088 View Registration
• APS MATERIALS INC. IRELAND Registration: 3007740680 View Registration
• Stryker (Suzhou) Medical Technology Co.,Ltd. Registration: 3007913880 View Registration
• Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 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
• SIGNATURE ORTHOPAEDICS PTY LIMITED Registration: 3008262872 View Registration
• ADLER ORTHO S.P.A. Registration: 3008281151 View Registration
• Limacorporate S.p.A. Registration: 3008395353 View Registration
• Lincotek Medical Registration: 3008421730 View Registration
• TOTAL JOINT ORTHOPEDICS, INC. Registration: 3008544874 View Registration
• LISI MEDICAL ORTHOPAEDICS Registration: 3008556682 View Registration
• Symmetry Medical Malaysia Sdn Bhd (758243-M) Registration: 3008572101 View Registration
• SERF Registration: 3008668801 View Registration
• Smith & Nephew, Inc. Registration: 3008744062 View Registration
• SAMAPLAST AG Registration: 3008793310 View Registration
• Swann-Morton(Services) Limited Registration: 3008812251 View Registration
• STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
• EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
• CORENTEC CO., LTD. Registration: 3009106092 View Registration
• CARAGH PRECISION Registration: 3009173317 View Registration
• TURNCO TOOL & INSTRUMENT, INC. Registration: 3009241418 View Registration
• LSM-MED S.r.l. Registration: 3009475821 View Registration
• HPF S.R.L. Registration: 3009546990 View Registration
• BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
• Synergy Health Ede BV Registration: 3009756327 View Registration
• UOC USA Inc. Registration: 3009760038 View Registration
• SYMMETRY MEDICAL IRELAND LIMITED Registration: 3009813841 View Registration
• SHEFFIELD PRECISION MEDICAL LTD Registration: 3009871135 View Registration
• PERRYMAN COMPANY Registration: 3009882462 View Registration
• Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
• Ferry Machine Corporation Registration: 3009959868 View Registration
• Engineered Medical Systems, LLC Registration: 3009973336 View Registration
• ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
• Mendell Registration: 3009998573 View Registration
• rms Surgical Registration: 3010009693 View Registration
• Lincotek Medical LLC Registration: 3010039400 View Registration
• ALMARK TOOL & MANUFACTURING COMPANY, INC. Registration: 3010041693 View Registration
• CULVER TOOL & ENGINEERING Registration: 3010047454 View Registration
• LH MEDICAL CORPORATION Registration: 3010057495 View Registration
• RAYCO STEEL PROCESS, INC. Registration: 3010065126 View Registration
• Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
• FLEX-CELL PRECISION, INC. Registration: 3010120135 View Registration
• Synergy Health Sterilisation UK Ltd Registration: 3010132111 View Registration
• Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
• APPLIMED SA -CSSR Registration: 3010163695 View Registration
• Synergy Health Westport Ltd Registration: 3010173425 View Registration
• IONISOS Registration: 3010178296 View Registration
• ARISTOTECH INDUSTRIES GMBH Registration: 3010206549 View Registration
• Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
• BAECHLER FEINTECH AG Registration: 3010287737 View Registration
• BGS Beta Gamma Service GmbH & Co KG Registration: 3010288357 View Registration
• INNOTOOL&GREMINGER AG Registration: 3010314800 View Registration
• FRUEH VERPACKUNGSTECHNIK AG Registration: 3010363503 View Registration
• PPD MEDITECH, DIV. OF INDUSTRIES PPD INC. Registration: 3010375065 View Registration
• SINGLE SOURCE MEDICAL LLC Registration: 3010386387 View Registration
• TRIGON INCORPORATED Registration: 3010468876 View Registration
• PRO-TECH Design & Mfg, Inc. Registration: 3010531069 View Registration
• MICROPORT ORTHOPEDICS INC. Registration: 3010536692 View Registration
• SAS ETABLISSEMENTS MAURICE MARLE Registration: 3010576282 View Registration
• MERIL HEALTHCARE PVT. LTD. Registration: 3010846112 View Registration
• INCIPIO DEVICES Registration: 3011015572 View Registration
• SURGTECH, INC. Registration: 3011170410 View Registration
• MID SOUTH PRECISION Registration: 3011189525 View Registration
• WESTLAKE PLASTICS EUROPE Registration: 3011274144 View Registration
• CEP BIO-COAT, LLC Registration: 3011277306 View Registration
• Suzhou Elite Precision Machinery Co., Ltd. Registration: 3011295718 View Registration
• Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
• KYOCERA Medical Corporation Shiga Yasu Plant Registration: 3012119238 View Registration
• MicroPort Orthopedics Global Supply Center Limited Registration: 3012130008 View Registration
• MARLE FINISHING SAS Registration: 3012275107 View Registration
• Zimmer Orthopedics Manufacturing Limited-Galway Registration: 3012319330 View Registration
• UNITED ORTHOPEDIC CORPORATION Registration: 3012329926 View Registration
• Zimmer Biomet Canada DFE Registration: 3012392319 View Registration
• KYOCERA Medical Corporation Registration: 3012425419 View Registration
• Mathys AG Bettlach Registration: 3012439458 View Registration
• implantcast GmbH Registration: 3012523063 View Registration
• Zimmer Biomet G.K. Registration: 3012725451 View Registration
• OPTIMIZED ORTHO PTY LTD Registration: 3012916784 View Registration
• Stryker Anngrove Registration: 3013014058 View Registration
• Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
• ZIMMER PTE. LTD. Registration: 3013176080 View Registration
• ARMBRUSTER GMBH Registration: 3013194153 View Registration
• ARVATO Netherlands B.V. Registration: 3013302242 View Registration
• Avalign Additive / Slice Manufacturing Studios Registration: 3013413393 View Registration
• ONKOS SURGICAL, INC. Registration: 3013450937 View Registration
• OEB S.R.L. Registration: 3013791180 View Registration
• 3D INSTRUMENTATION SDN BHD Registration: 3014170143 View Registration
• C&A Tool Engineering, Inc. Auburn Plant Registration: 3014252644 View Registration
• GMED Healthcare BVBA ( a Johnson & Johnson Company) Registration: 3014272734 View Registration
• NOVOSOURCE, LLC Registration: 3014273644 View Registration
• BIOMET CHILE S.A. Registration: 3014302784 View Registration
• Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration
• b-ONE Medical (Beijing) Co., Ltd. Registration: 3014644608 View Registration
• Signature Orthopaedics Europe Ltd Registration: 3014763043 View Registration
• restor3d, inc. Registration: 3014833750 View Registration
• B-ONE MEDICAL (SUZHOU) CO., LTD. Registration: 3015167917 View Registration
• Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
• B-ONE ORTHO, CORP. Registration: 3015259876 View Registration
• Kyocera Medical Technologies, Inc. Registration: 3015398319 View Registration
• Depuy Ireland UC Registration: 3015516266 View Registration
• Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
• ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
• ABBOTT LABORATORIES Registration: 3016438761 View Registration
• LINCOTEK BOLOGNA S.R.L. Registration: 3016778562 View Registration
• EDDI BRESSAN S.R.L. Registration: 3017397663 View Registration
• AKSHAR GAMMA STERILES LLP Registration: 3018052045 View Registration
• CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
• SHALBY ADVANCED TECHNOLOGIES, INC. Registration: 3020155054 View Registration
• APS Materials Suzhou Registration: 3020282716 View Registration
• ProMade PoC Center for Complex Orthopedic Solutions at HSS Registration: 3020967480 View Registration
• ARVATO USA LLC Registration: 3021008900 View Registration
• LINCOTEK (WUXI) CO., LTD. Registration: 3021386586 View Registration
• Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration
• Hipp Medical AG Registration: 3023852420 View Registration
• STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
• STI LUALDI S.R.L. Registration: 3026771806 View Registration
• VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) Registration: 3026776 View Registration
• VALTECNE SPA Registration: 3027484613 View Registration
• XERXES ARTHROPEDIX Registration: 3030338875 View Registration
• GLOBUS MEDICAL, INC. Registration: 3030412764 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
• Adler Ortho SpA Registration: 3036773273 View Registration
• Mathys Orthopaedie GmbH Registration: 3036795922 View Registration
• Smith & Nephew, Inc. Registration: 3038503932 View Registration
• b-ONE Ortho Corp. Registration: 3042508254 View Registration
• FERRY MACHINE CORPORATION Registration: 3043543260 View Registration
• DEPUY INTL., LTD. Registration: 8010379 View Registration
• STERIS Schweiz AG Registration: 8043792 View Registration
• CERAMTEC GmbH Medical Products Division Registration: 8044172 View Registration
• AESCULAP AG Registration: 9610612 View Registration
• HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration
• ZIMMER GMBH Registration: 9613350 View Registration
• SMITH & NEPHEW ORTHOPAEDICS AG Registration: 9613369 View Registration
• Corin Limited Registration: 9614209 View Registration
• Viant Chaumont S.A.S. Registration: 9615674 View Registration
• CHARLES PERY & CIE Registration: 9615800 View Registration
• DEPUY (IRELAND) Registration: 9616671 View Registration
• STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
• SYNTEC SCIENTIFIC CORP. Registration: 9616944 View Registration
• ZIMMER CAS Registration: 9617840 View Registration
• Gammatom S.r.l. Registration: 9681465 View Registration
• UNITED ORTHOPEDIC CORP. Registration: 9681642 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.