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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: ACCESSORY INSTRUMENTS FOR BIONE PLATING SYSTEM, PROVIDED STERILE/NON-STERILE Proprietary Device Name: INION CPS INSTRUMENTS Registered Establishment Name: INION LTD.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE FIXATION FASTNER Proprietary Device Name: SCREW, FIXATION, BONE (MULTIPLE BRANDS) Registered Establishment Name: INION LTD.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATE Proprietary Device Name: INION OTPS Registered Establishment Name: INION LTD.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: BONE PIN Proprietary Device Name: OTPS BIODEGRADABLE PIN Registered Establishment Name: INION LTD.. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Proprietary Device Name: INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM Registered Establishment Name: INION LTD.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL PLATE, SPINAL SHEET Proprietary Device Name: INION S-1 BIODEGRADABLE ACFS Registered Establishment Name: INION LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ARTHROSCOPIC INSTRUMENTS AND LIGAMENT RECONSTRUCTION ACCESSORIES Proprietary Device Name: ATLANTECH Registered Establishment Name: ARTHOCARE UK, LTD.. |
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Classification: BIT, DRILL Generic Device Name: DRILLS, CANNULATED Proprietary Device Name: ATLANTECH LIGAMENT TUNNEL DRILLS Registered Establishment Name: ARTHOCARE UK, LTD.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPES, 2.7 MM AND 4.0 MM Proprietary Device Name: ATLANTECH Registered Establishment Name: ARTHOCARE UK, LTD.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF SCREWS Proprietary Device Name: BIOLOK SCREWS/ATLANTECH GRAFT FIXATION SCREW Registered Establishment Name: ARTHOCARE UK, LTD.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NEEDLE HOLDER Proprietary Device Name: MULTIPLE Registered Establishment Name: RAINER ROSENKRANZ CHIRURGISCHE INSTRUMENTE MANUFAC. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER Proprietary Device Name: MULTIPLE Registered Establishment Name: RAINER ROSENKRANZ CHIRURGISCHE INSTRUMENTE MANUFAC. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: GLOBAL SPINAL FIXATION SYSTEM, SPINAL HOOK SYSTEM Registered Establishment Name: U&I CORP.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OPTIMA SPINAL SYSTEM Registered Establishment Name: U&I CORP.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OPTIMA SPINAL SYSTEM, GLOBAL SPINAL FIXATION SYSTEM Registered Establishment Name: U&I CORP.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: OPTIMA SPINAL SYSTEM, GLOBAL SPINAL FIXATION SYSTEM Registered Establishment Name: U&I CORP.. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: AWL Registered Establishment Name: U&I CORP.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: COMPRESSOR INSTRUMENT Proprietary Device Name: COMPRESSOR Registered Establishment Name: U&I CORP.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP Proprietary Device Name: TAP-4.OMM, TAP-5.OMM, TAP-6.OMM, TAP-7.0MM, TAP-7.5MM, TAP-8.0MM Registered Establishment Name: U&I CORP.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE, CURVED PROBE Registered Establishment Name: U&I CORP.. |
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Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: TORQUE WRENCH FOR T LINK-COLLET TYPE, AXIAL TORQUE WRENCH, DEROTATOR Registered Establishment Name: U&I CORP.. |
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Classification: FORK Generic Device Name: FORK Proprietary Device Name: ROD FORK Registered Establishment Name: U&I CORP.. |
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Classification: PUSHER, SOCKET Generic Device Name: SOCKET PUSHER Proprietary Device Name: ROD PUSHER Registered Establishment Name: U&I CORP.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: BENDING INSTRUMENT Proprietary Device Name: IN-SITU ROD BENDER-RIGHT, IN-SITU ROD BENDER-LEFT Registered Establishment Name: U&I CORP.. |
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Classification: BENDER Generic Device Name: ROD BENDER Proprietary Device Name: ROD BENDER Registered Establishment Name: U&I CORP.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: 2.5MM HEX DRIVER, POLY SCREW DRIVER, MONO SCREW DRIVER, LARGE POLY SCREW DRIVER, Registered Establishment Name: U&I CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: SPREADER,GUIDE PIN (SM,LG), TESTER(STRAIGHT, CURVED),PERSUADER,ROCKER,RATCHET HA Registered Establishment Name: U&I CORP.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: ROD TEMPLATE 200MM, ROD TEMPLATE 400MM Registered Establishment Name: U&I CORP.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: DEPTH GAUGE Registered Establishment Name: U&I CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: HEALING SURGICAL CORP.. |
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Classification: TEMPLATE Generic Device Name: ANATOMICAL MODELS Proprietary Device Name: CLEARVIEW(TM) ANATOMICAL MODEL, RAPIDVIEW(TM) ANATOMICAL MODEL Registered Establishment Name: MEDICAL MODELING LLC. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF NEEDLES HOLDERS Proprietary Device Name: HOLDER, NEEDLE; ORTHOPEDIC Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF WIRE PASSERS Proprietary Device Name: PASSER, WIRE, ORTHOPEDIC Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES HIGH SPEED DRILLS Proprietary Device Name: BIT, DRILL Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: MULTIPLE Proprietary Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: OLECRANON SCREW Proprietary Device Name: SYSTEM, EXTERNAL FIXATOR (WITH NON-METALLIC INVASIVE COMPONENTS) Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF GONIOMETERS Proprietary Device Name: GONIOMETER, NONPOWERED Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: PASSER Generic Device Name: TENDON PASSER Proprietary Device Name: PASSER Registered Establishment Name: BOWEN SURGICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: MIR GROUP OF INDUSTRIES. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: ARTHROSCOPE Registered Establishment Name: GLOBAL ENDOSCOPY, INC.. |
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