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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, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: VARIOUS SIZES & DESIGNS OF FEMORAL HIP STEMS Proprietary Device Name: UNI-STEM HIP PROSTHESIS, MODULAR PLUS REVISION STEMS, SL-PLUS LATERALIZED STEMS Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: VARIOUS SIZES & DESIGNS OF ACETABULAR CUPS, INSERTS AND BALL HEADS Proprietary Device Name: BOFOR REVISION CUP, MPF ACETABULAR CUPS GEN II, MPF ACETABULAR CUPS Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: CALCIUM SULFATE Proprietary Device Name: STIMULAN Registered Establishment Name: BIOCOMPOSITES LTD.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BIORESORBABLE INTERFERENCE SCREW Proprietary Device Name: BILOK SCREW Registered Establishment Name: BIOCOMPOSITES LTD.. |
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Classification: STARTER, BONE SCREW Generic Device Name: TUNNEL DILATOR Proprietary Device Name: BILOK DILATOR Registered Establishment Name: BIOCOMPOSITES LTD.. |
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Classification: TAP, BONE Generic Device Name: ACL BONE TAP Proprietary Device Name: BILOK TAP Registered Establishment Name: BIOCOMPOSITES LTD.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: BILOK DRIVER Registered Establishment Name: BIOCOMPOSITES LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ALLOFIX CORTICAL BONE PIN INSERTION KIT Proprietary Device Name: ALLOFIX CORTICAL BONE PIN INSERTION KIT Registered Establishment Name: MUSCULOSKELETAL TRANSPLANT FOUNDATION. |
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Classification: GAUGE, DEPTH Generic Device Name: SBS" TRIAL SPACER Proprietary Device Name: SBS" TRIAL SPACER Registered Establishment Name: MUSCULOSKELETAL TRANSPLANT FOUNDATION. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE VOID FILLER CONTAINING HUMAN DEMINERALIZED MATRIX Proprietary Device Name: DBX STRIP Registered Establishment Name: MUSCULOSKELETAL TRANSPLANT FOUNDATION. |
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Classification: PROSTHESIS, TOE, HEMI-, PHALANGEAL Generic Device Name: PHALANGEAL JOINT IMPLANT Proprietary Device Name: SILIMED PHALANGEAL JOINT IMPLANT Registered Establishment Name: SILIMED-SILICONE E INSTRUMENTAL MEDICO-CIRURGICO E. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: PLEASANT SURGICO Registered Establishment Name: PLEASANT SURGICO. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ORIA SPINAL CLIP SYSTEM Proprietary Device Name: ORIA SPINAL CLIP SYSTEM Registered Establishment Name: EUROSURGICAL S.A.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: ORIA SPINAL CLIP SYSTEM Proprietary Device Name: ORIA SPINAL CLIP SYSTEM Registered Establishment Name: EUROSURGICAL S.A.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: ORIA SPINAL CLIP SYSTEM Proprietary Device Name: ORIA SPINAL CLIP SYSTEM Registered Establishment Name: EUROSURGICAL S.A.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: ORIA SPINAL CLIP SYSTEM Proprietary Device Name: ORIA SPINAL CLIP SYSTEM Registered Establishment Name: EUROSURGICAL S.A.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS SIZES OF CRUCIFORM SCREWDRIVERS Proprietary Device Name: CRUCIFORM SCREWDRIVER Registered Establishment Name: DOCTOR'S RESEARCH GROUP, INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: THREADED METALLIC BONE FIXATION FASTENER, VARIOUS TYPES & SIZES Proprietary Device Name: SHERLOCK THREADED SUTURE ANCHOR Registered Establishment Name: DOCTOR'S RESEARCH GROUP, INC.. |
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Classification: BONE CEMENT Generic Device Name: BONE CEMENT, BONE VOID FILLER Proprietary Device Name: DRG KRYPTONITE BONE CEMENT Registered Establishment Name: DOCTOR'S RESEARCH GROUP, INC.. |
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Classification: PROSTHESTIC DISC NUCLEUS DEVICE Generic Device Name: PROSTHETIC DISC NUCLEUS DEVICE Proprietary Device Name: PDN PROSTHETIC DISC NUCLEUS Registered Establishment Name: RAYMEDICA, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE AND ACCESSORIES Proprietary Device Name: ARTHROSCOPE IRRIGATION SYSTEM Registered Establishment Name: DAVOL SURGICAL INNOVATIONS. |
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Classification: BIT, DRILL Generic Device Name: TWIST DRILL Proprietary Device Name: TWIST DRILL Registered Establishment Name: SPHINX TOOLS LTD.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: GII SPINAL FIXATION SYSTEM Registered Establishment Name: CO-LIGNE AG. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS Proprietary Device Name: GII SPINAL FIXATION SYSTEM Registered Establishment Name: CO-LIGNE AG. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: GII SPINAL FIXATION SYSTEM Registered Establishment Name: CO-LIGNE AG. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE VARIOUS SIZES Proprietary Device Name: DEPTH GAUGE Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: REAMER Generic Device Name: BONE-REAMER Proprietary Device Name: REAMER-BONE Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: STARTER, BONE SCREW Generic Device Name: STARTER FOR SCREW - BONE Proprietary Device Name: BONE SCREW STARTER Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: DRIVER, PROSTHESIS Generic Device Name: PROSTHESIS DRIVING INSTRUMENT Proprietary Device Name: PROSTHESIS DRIVER Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: TAP, BONE Generic Device Name: BONE TAP ALL SIZES Proprietary Device Name: TAP, BONE Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: TWISTER, WIRE Generic Device Name: WIRE TWISTER- ALL TYPES AND SIZES Proprietary Device Name: WIRE TWISTER Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: ORTHOPEDIC WIRE PASSER Proprietary Device Name: ORTHOPEADIC WIRE PASSER Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: BRACE, DRILL Generic Device Name: DRILL BRACE ALL TYPES Proprietary Device Name: DRILL BRACE Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER-ALL TYPES Proprietary Device Name: WIRE CUTTER Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC SURGICAL INSTRUMENTS - MANUAL ALL TYPES & SIZES Proprietary Device Name: ORTHOPEDIC SURGICAL INSTRUMENTS - MANUAL Registered Establishment Name: GENERAL SURGICAL CO., (INDIA) PVT. LTD.. |
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Classification: ARTHROSCOPE Generic Device Name: TUBING SET Proprietary Device Name: MTP ARTHROPUMP TUBING SET Registered Establishment Name: EMS MEDICAL, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: VERTEBRAL DISTRACTION PUMP (V.D.P.) Proprietary Device Name: VERTEBRAL DISTRACTION PUMP (V.D.P.) Registered Establishment Name: BRAY CORPORATION. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: VARIOUS TYPES Proprietary Device Name: MULTIPLE Registered Establishment Name: HU-FRIEDY MFG. CO.,INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: VARIOUS ORTHOPEDIC KNIVES,STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDISISS. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS,STERILE Proprietary Device Name: MULTIPLE Registered Establishment Name: MEDISISS. |
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