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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
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Classification: PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED) Generic Device Name: INTERPOSITIONAL SPACER, FIXED MENISCUS IMPLANT Proprietary Device Name: MULTIPLE Registered Establishment Name: SALUMEDICA, L.L.C.. |
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Classification: GONIOMETER, AC-POWERED Generic Device Name: SPINALMOUSE Proprietary Device Name: SPINALMOUSE Registered Establishment Name: IDIAG. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: JOSEF SCHWARZ. |
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Classification: COMPONENT, CAST Generic Device Name: MEDICAL PLASTER, COLD PLASTER POWDER Proprietary Device Name: MEDICAL PLASTER, COLD PLASTER POWDER Registered Establishment Name: GUANGXI YUAN'ANTANG PHARMACEUTICAL FACTORY. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CHANGEUI MEDICAL CO., LTD.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: HOLDER, NEEDLE; ORTHOPEDIC Proprietary Device Name: MULTIPLE Registered Establishment Name: EVERLAST SURGICAL CO.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS, ORTHOPEDIC Proprietary Device Name: MULTIPLE Registered Establishment Name: EVERLAST SURGICAL CO.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: BOWLS Proprietary Device Name: STAINLESS STEEL BOWLS Registered Establishment Name: TRIMED INSTRUMENTAIS. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: RONGEUR Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: STRIPPER, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: PROBE Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: STILLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS TYPES OF MANUAL CAST REMOVAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: STILLE SURGICAL AB. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION APPLIANCE Proprietary Device Name: WELLONG SPINAL FIXATION SYSTEM Registered Establishment Name: WELLONG INSTRUMENTS CO., LTD.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: GONIOMETER, NONPOWERED Registered Establishment Name: DONGGUAN XIE GANG KONGLOON METAL PLASTIC MFY.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: FIXATION BONE PLATE, DISTAL RADIUS FRACTURE REPAIR SYSTEM, DISTOL VOLAR RADIUS Proprietary Device Name: DISTAL NAIL PLATE ANATOMICAL, DISTAL RADIUS FRACTURE REPAIR SYSTEM, DISTAL VOLAR Registered Establishment Name: HAND INNOVATIONS, LLC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: PLATE FIXATION BONE Proprietary Device Name: FRAGMENT PLATE SYSTEM Registered Establishment Name: HAND INNOVATIONS, LLC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: SMALL BONE FIXATION SYSTEM Proprietary Device Name: K-WIRE Registered Establishment Name: HAND INNOVATIONS, LLC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: PLATE FIXATION BONE Proprietary Device Name: DISTAL RADIUS ANATOMICAL PLATE SYSTEM, SHOULDER FIXATION SYSTEM Registered Establishment Name: HAND INNOVATIONS, LLC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: PERFECTRA INSTRUMENTS Registered Establishment Name: M/S. PERFECTRA INSTRUMENTS. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: PAK AXIS INTL.. |
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Classification: SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM Generic Device Name: MULTI & VARIOUS Proprietary Device Name: DEPUY ACROMED Registered Establishment Name: MILLSTONE MEDICAL OUTSOURCING LLC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: MULTIPLE & VARIOUS Proprietary Device Name: DEPUY ACRO MED Registered Establishment Name: MILLSTONE MEDICAL OUTSOURCING LLC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: HIP PROSTHESIS Proprietary Device Name: APEX MODULAR HIP SYSTEM Registered Establishment Name: MILLSTONE MEDICAL OUTSOURCING LLC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES OF INTERNAL FIXATION APPLIANCES AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: MILLSTONE MEDICAL OUTSOURCING LLC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: FIXATION, NAIL, BLADE, PLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: MILLSTONE MEDICAL OUTSOURCING LLC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: DEFOE INTL.. |
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Classification: RONGEUR Generic Device Name: RONGUERS Proprietary Device Name: RONGUERS Registered Establishment Name: DEFOE INTL.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE Proprietary Device Name: SYNTHACER CALCIUM SALT BONE VOID FILLER &SYNTRICER CALCIUM SALT BONE VOID FILLER Registered Establishment Name: MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: STAPLE Proprietary Device Name: SCAPHIX Registered Establishment Name: MICHAEL'S FRANCE. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION APPARATUS Proprietary Device Name: SHOULDER TRACTION KIT Registered Establishment Name: CARDINAL HEALTH. |
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Classification: PROBE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ALTOMED LTD.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: CEMENT MIXER Proprietary Device Name: MIXER Registered Establishment Name: CORINTHIAN SURGICAL LTD.. |
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Classification: COMPONENT, CAST Generic Device Name: COMPONENT CAST Proprietary Device Name: BARSCH Registered Establishment Name: SUKOL SCIENTIFIC, INC.. |
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