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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/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS Proprietary Device Name: ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: THE LIGAMENT ANCHOR SOFT CHEW Proprietary Device Name: CORIFIX LIGAMENT ANCHOR SOFT SCREW Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: ROTAGLIDE+MODULAR KNEE SYSTEM W/ FIXED MENISCUS Proprietary Device Name: ROTAGLIDE+MODULAR KNEE SYSTEM W/ FIXED MENISCUS Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: ROD-TO-ROD SPINAL CROSS BRACE W/ CORIN SPINAL SYSTEM Proprietary Device Name: ROD-TO-ROD SPINAL CROSS BRACE Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: PROSTHESIS, HIP, FEMORAL, RESURFACING Generic Device Name: HIP JOINT FEMORAL (HEMI HIP) METALLIC PROSTHESES Proprietary Device Name: CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESES Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: FEMORAL STEM Proprietary Device Name: TRI-FIT FEMORAL HIP SYSTEM Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: UNIGLIDE Proprietary Device Name: UNIGLIDE UNICONDYLAR KNEE REPLACMENT SYSTEM Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: THE DAY COMPRESSION BONE STAPLE Proprietary Device Name: DAY STAPLE Registered Establishment Name: CORIN MEDICAL, LTD.. |
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Classification: WASHER, BOLT NUT Generic Device Name: SUTURE WASHER Proprietary Device Name: MED-SURG SUTURE WASHER Registered Establishment Name: MEDICAL SURGICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS (GENERAL) Proprietary Device Name: A.N.A. AMITY IMPEX Registered Establishment Name: A.N.A. AMITY IMPEX. |
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Classification: CUTTER, WIRE Generic Device Name: CUTTER WIRE Proprietary Device Name: A.N.A. AMITY IMPEX Registered Establishment Name: A.N.A. AMITY IMPEX. |
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Classification: RONGEUR Generic Device Name: RONGEURS Proprietary Device Name: A.N.A. AMITY IMPEX Registered Establishment Name: A.N.A. AMITY IMPEX. |
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Classification: TAMP Generic Device Name: TAMP Proprietary Device Name: A.N.A. AMITY IMPEX Registered Establishment Name: A.N.A. AMITY IMPEX. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: A.N.A. AMITY IMPEX Registered Establishment Name: A.N.A. AMITY IMPEX. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE SUBSTITUTE MATERIAL BONE VOID FILLER BONE GRAFT MATERIAL Proprietary Device Name: ALPHA BSM BONE SUBSTITUTE MATERIAL Registered Establishment Name: ETEX CORP.. |
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Classification: COMPONENT, CAST Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ORFIT INDUSTRIES NV. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: MULTI PURPOSE HIP ENDPROSTHESIS STEM Proprietary Device Name: MULTI PURPOSE PROTHESIS (MPP) Registered Establishment Name: HIPOKRAT TIBBI MALZEMELER IMALAT VE PAZARLAMA A.S. |
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Classification: BIT, DRILL Generic Device Name: DRILL BITS Proprietary Device Name: ACP DRILL ASSEMBLY Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: TAP, BONE Generic Device Name: BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: WRENCH Generic Device Name: SURGICAL WRENCH & ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: TWISTER, WIRE Generic Device Name: WIRE TWISTING INSTRUMENT Proprietary Device Name: OCHSNER WIRE TWISTER Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: BENDER Generic Device Name: BENDING INSTRUMENT Proprietary Device Name: ACP CONTOUR BENDER Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: FIXATION ACCESSORY Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: WIRE, SURGICAL Generic Device Name: SURGICAL WIRE Proprietary Device Name: SOFWIRE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: FIXATION CERCLAGE WIRE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: VARIOUS COMPONENTS FOR SPINAL FIXATION Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: TEMPLATE Generic Device Name: VARIOUS TEMPLATES FOR CLINICAL USE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: STERNAL KNIFE Proprietary Device Name: LEBSCHE STERNAL KNIFE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS SCISSORS FOR ORTHOPEDIC USE Proprietary Device Name: NONE Registered Establishment Name: CODMAN & SHURTLEFF, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: MULTIPLE Registered Establishment Name: GYRUS MEDICAL LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: PROSTHESIS,HIP,CERAMIC BALL Proprietary Device Name: PROZYR Registered Establishment Name: CERAMIGUES TECHNIQUES DESMARQUEST. |
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Classification: RONGEUR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: STOEHR MEDIZINTECHNIK. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: MAMOASH IMPEX. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS Registered Establishment Name: BEMA-GMBH & CO. KG. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: RYCOR FINGER AND HAND TRAP Proprietary Device Name: RYCOR FINGER AND HAND TRAP Registered Establishment Name: RYCOR MEDICAL, INC.. |
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