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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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES AND SIZES OF ORTHOPAEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERVERTEBRAL,FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERLAMINAL FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES SIZES OF NONPOWERED GONIOMETERS Proprietary Device Name: GONIOMETER Registered Establishment Name: SYNTHES (USA). |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE INVASIVE TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PIN, FIXATION, THREADED Generic Device Name: VARIOUS TYPES AND SIZES OF THREADED FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF BONE FIXATION NAILS.,STERILE AND NON-STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: CERCLAGE, FIXATION Generic Device Name: VARIOUS TYPES AND SIZES OF FIXATION CERCLAGES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: VARIOUS TYPES AND SIZES OF PROXIMAL FEMUR,FIXATION DEVICE,APPLIANCES,STERILE AND Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS TYPES AND SIZES OF INTRAMEDULLARY FIXATION RODS, STERILE AND NON-STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: STARTER, BONE SCREW Generic Device Name: VARIOUS TYPES AND SIZES OF BONE SCREW STARTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES AND SIZES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: COUNTERSINK Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: EXTRACTOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: AWL Generic Device Name: VARIOUS Proprietary Device Name: AWL Registered Establishment Name: SYNTHES (USA). |
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Classification: REAMER Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: DISPENSER, CEMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ARTHROSCOPE Generic Device Name: ACCESSORIES ARTHROSCOPIC Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: MONITOR, PRESSURE, INTRACOMPARTMENTAL Generic Device Name: COMPARTMENTAL PRESSURE MONITORING SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES AND SIZES OF EXTERNAL FIXATION CLAMPS, RODS, BARS, AND TUBES, ETC. Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PROSTHESIS, RIB REPLACEMENT Generic Device Name: VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR Proprietary Device Name: VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR Registered Establishment Name: SYNTHES (USA). |
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Classification: PROBE Generic Device Name: VARIOUS OPTHALMIC PROBES Proprietary Device Name: ACCUTOME Registered Establishment Name: ACCUTOME, INC.. |
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Classification: DISPENSER, CEMENT Generic Device Name: CEMENT GUN Proprietary Device Name: ENHANCEMENT GUN Registered Establishment Name: PRECISION MEDICAL DEVICES, INC.. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: TIBIAL RETRACTOR Proprietary Device Name: TIBIAL RETRACTOR Registered Establishment Name: PRECISION MEDICAL DEVICES, INC.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: CEMENT MIXER Proprietary Device Name: MIXER, CEMENT, FOR CLINICAL USE Registered Establishment Name: PRECISION MEDICAL DEVICES, INC.. |
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Classification: FILE Generic Device Name: ORTHOPEDIC BONE FILE Proprietary Device Name: MILTEX Registered Establishment Name: MILTEX, INC.. |
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Classification: PROBE Generic Device Name: ORTHOPEDIC PROBE Proprietary Device Name: MILTEX Registered Establishment Name: MILTEX, INC.. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: CAST REMOVAL SPREADERS AND KNIVES Proprietary Device Name: MULTIPLE Registered Establishment Name: MILTEX, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: STEINMANN SMOOTH FIXATION PIN Proprietary Device Name: MULTIPLE Registered Establishment Name: MILTEX, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: STEINMANN THREADED FIXATION PIN Proprietary Device Name: MULTIPLE Registered Establishment Name: MILTEX, INC.. |
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Classification: TAMP Generic Device Name: BONE TAMP, VARIOUS MODELS Proprietary Device Name: MILTEX Registered Establishment Name: MILTEX, INC.. |
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Classification: TEMPLATE Generic Device Name: SURGI-GUIDE TEMPLATE Proprietary Device Name: MILTEX TEMPLATE Registered Establishment Name: MILTEX, INC.. |
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