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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: COMPONENT, CAST Generic Device Name: CIRCULAR CAST FOR UPPER & LOWER LIMB (ORTHOPEDIC) Proprietary Device Name: X-LIFE Registered Establishment Name: RUNLITE S.A.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: CARVAS WEIGHT BAG Proprietary Device Name: CANVAS WEIGHT BAG Registered Establishment Name: VIJAY SCIENTIFIC AND SURGICAL CO.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: CERVICAL COLLAR Proprietary Device Name: CERVICAL COLLAR STD Registered Establishment Name: VIJAY SCIENTIFIC AND SURGICAL CO.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VINYL WATER WEIGHT BAG Proprietary Device Name: VINYL WATER WEIGHT BAG Registered Establishment Name: WINMED INSTRUMENTS MFG. CORP.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS, EASY SQUEEZE Registered Establishment Name: WINMED INSTRUMENTS MFG. CORP.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: TEMPLATE Generic Device Name: VARIOUS SIZES AND TYPES OF TRIAL PROSTHESIS, ACETABULAR, CUPS, INSERTS AND HEADS Proprietary Device Name: FURLONG TOTAL HIP REPLACEMENT SYSTEM Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Generic Device Name: VARIOUS SIZES & TYPES OF H-A-C COATED PROSTHESIS, ACETABULAR CUPS, INSERTS AND S Proprietary Device Name: FURLONG HYDROXIAPATITE CERAMIC TOTAL HIP REPLACEMENT SYSTEM Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: VARIOUS TYPES OF INSTRUMENTS USED FOR THE FITTING AND REVISION OF HIPS Proprietary Device Name: FURLONG HA-C TOTAL HIP REPLACEMENT SYSTEM Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF INSTRUMENTS USED FOR THE FITTING AND REVISION OF HIPS Proprietary Device Name: FURLONG HA-C TOTAL HIP REPLACEMENT SYSTEM Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: VARIOUS SIZES AND TYPES OF HA-C COATED PROSTHESIS, ACE TABULAR CUPS, INSERTS Proprietary Device Name: FURLONG HA-C TOTAL HIP REPLACEMENT SYSTEM Registered Establishment Name: J.R.I. MFG., LTD.. |
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Classification: IMPACTOR Generic Device Name: VARIOUS TYPES IMPACTOR Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: NIC INSTRUMENTS LTD.. |
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Classification: BRACE, DRILL Generic Device Name: VARIOUS TYPES BRACE DRILL Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: NIC INSTRUMENTS LTD.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS TYPES KUNTSCHER BONE NAIL Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: NIC INSTRUMENTS LTD.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: SURGICRAFT RECTANGLES AND WIRES Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: DRILL GUIDE/DRILL JIG/GUIDE WIRE JIG Proprietary Device Name: RHINO HORN ACL JIG Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL IMPLANT Proprietary Device Name: RANSFORD LOOP (CERVIAL FIXATION SYSTEM) Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: BONE FIXATION/FASTENER Proprietary Device Name: BONE TIE Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: SURGICAL INSTRUMENT Proprietary Device Name: STALIF TT SURGICAL INSTRUMENT Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT DEVICE Proprietary Device Name: STALIF TT Registered Establishment Name: SURGICRAFT LTD.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: PUNCH, FEMORAL NECK Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: RONGEUR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: CORKSCREW Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: B. BRAUN MEDICAL LTD. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Generic Device Name: VARIOUS SIZES OF ACETABULAR COMPONENT AND HIP PROTHESIS WITHOUT CEMENT Proprietary Device Name: PROFESSOR R.JUDET HIP PROTHESIS PORO METAL Registered Establishment Name: TORNIER. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL FIXATOR - ANTERIOR SPINAL FIXATOR Proprietary Device Name: KLUGER SPINAL FIXATOR, K.S.F. SPINAL FIXATOR FOR ANTERIOR SPINAL FIXATION Registered Establishment Name: TORNIER. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: TOTAL SHOULDER SYSTEM Proprietary Device Name: AEQUALIS SHOULDER SYSTEM Registered Establishment Name: TORNIER. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: TORNIER LATITUDE PROSTHESIS Proprietary Device Name: TORNIER LATITUDE PROSTHESIS Registered Establishment Name: TORNIER. |
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Classification: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Generic Device Name: TORNIER LATITUDE PROSTHISIS Proprietary Device Name: TORNIER LATITUDE PROSTHISIS Registered Establishment Name: TORNIER. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT) Generic Device Name: TOTAL HIP BM PROTHESIS Proprietary Device Name: TOTAL HIP BM PROTHESIS Registered Establishment Name: MEDICALEX. |
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Classification: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Generic Device Name: DR MAUDHUIT BLADE PLATE Proprietary Device Name: DR MAUDHUIT BLADE PLATE Registered Establishment Name: MEDICALEX. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: MEDICALPLASTIC. |
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