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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: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL PEDICLE FIXATION SYSTEMS Proprietary Device Name: SILHOUETTE SPINAL FIXATION SYSTEM, ST 360 SPINAL FIXATION SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: ROD, HOOK, AND SCREW SPINAL DEVICES Proprietary Device Name: SILHOUETTE SPINAL FIXATION SYSTEM, ST 360 SPINAL FIXATION SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: BENDING OR CONFORMING INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAGUE Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: TAMP Generic Device Name: TAMP Proprietary Device Name: SOFT GRAFT TAMP Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: LEG HOLDER WITH INTEGRATED TOURNIQUET Proprietary Device Name: ARTHROSCOPY LEG HOLDER Registered Establishment Name: MICTRON, INC.. |
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Classification: KNIFE, ORTHOPEDIC Registered Establishment Name: I.T.I., INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: CLINICAL HEAD HALTER Registered Establishment Name: THE SAUNDERS GROUP. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: TRACTION DEVICE Proprietary Device Name: SAUNDERS CERVICAL HOMETRAC Registered Establishment Name: THE SAUNDERS GROUP. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: INCLINOMETER Proprietary Device Name: SUANDERS ELECTRONIC INCLINOMETER Registered Establishment Name: THE SAUNDERS GROUP. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: CERVICAL TRACTION DEVICE Proprietary Device Name: SAUNDERS CERVICAL HOMETRAC Registered Establishment Name: THE SAUNDERS GROUP. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: TRACTION WEIGHTS Registered Establishment Name: FARETEC, INC.. |
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Classification: SPLINT, TRACTION Generic Device Name: TRACTION LEG SPLINT Proprietary Device Name: ARTICULATED LEG SPLINT Registered Establishment Name: FARETEC, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS, GRASPING FORCEPS, DISSECTING FORCEPS, NEEDLE HOLDERS Proprietary Device Name: ENDO-MED OPERATING-INSTRUMENTS FOR LAPAROSCOPIC USE Registered Establishment Name: ENDO-MED THECHNICS USA. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: MICRO ENGINEERING CO.. |
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Classification: INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT Generic Device Name: LISTON BONE CUTTING FORCEPS Proprietary Device Name: TAMSCO Registered Establishment Name: MICRO ENGINEERING CO.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: HENNING PLASTER SPREADER,CAST PLASTER SPREADER Proprietary Device Name: TAMSCO Registered Establishment Name: MICRO ENGINEERING CO.. |
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Classification: CUTTER, WIRE Generic Device Name: CUTTER, WIRE Proprietary Device Name: MICRO ENGINEERING CO. Registered Establishment Name: MICRO ENGINEERING CO.. |
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Classification: POSITIONER, SOCKET Generic Device Name: TONGUE POSITIONER AND EXCERCISER,TONGUE POSITIONER AND EXERCISER PALATE. Proprietary Device Name: TONGUE POSITIONER AND EXCERCISER,TONGUE POSITIONER AND EXERCISER PALATE. Registered Establishment Name: ALLESEE ORTHODONTIC APPLIANCES. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS TYPES OF ARTHROSCOPES Proprietary Device Name: MULTIPLE Registered Establishment Name: HENKE SASS WOLF OF AMERICA, INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: VARIOUS TYPES OF BENDING, ADAPTING AND CONTOURING EQUIPMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS SCREW RETRIEVER AND EXTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: WRENCH Generic Device Name: VARIOUS TYPES AND SIZES OF WRENCHES Proprietary Device Name: WRENCH Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF SCREW DRIVER Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: IMPACTOR Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: VARIOUS TYPES AND SIZES Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS TYPES AND SIZES Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: VARIOUS SIZES OF SUTURE ANCHORS Proprietary Device Name: SUTURE ANCHOR Registered Establishment Name: CLARKE MFG., INC.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: OLSEN-HEGAR, MAYO-HEGAR Proprietary Device Name: TAMSCO, MULTIPLE Registered Establishment Name: TRANS PAK INDUSTRIES. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTING SCISSORS, ANGULAR Proprietary Device Name: TAMSCO, MULTIPLE Registered Establishment Name: TRANS PAK INDUSTRIES. |
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Classification: CUTTER, WIRE Generic Device Name: CUTTER WIRE Proprietary Device Name: VARIOUS CUTTERS Registered Establishment Name: T.A.G. MEDICAL PRODUCTS. |
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Classification: BIT, DRILL Generic Device Name: ORTHOPEDIC DRILL BITS Proprietary Device Name: VARIOUS DRILL BITS Registered Establishment Name: T.A.G. MEDICAL PRODUCTS. |
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Classification: STRIPPER, SURGICAL Generic Device Name: SURGICAL STRIPPER Proprietary Device Name: TENDON STRIPPER Registered Establishment Name: T.A.G. MEDICAL PRODUCTS. |
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