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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: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILL BITS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF DRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS TYPES OF EXTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: COUNTERSINK Generic Device Name: VARIOUS TYPES OF COUNTERSINKS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS TYPES OF COMPRESSION INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES OF WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: WASHER Proprietary Device Name: BONE-LOK HP WASHER Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: TAP, BONE Generic Device Name: TAP Proprietary Device Name: HP TAP, 7.3MM Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: SYSTEM, FACET SCREW SPINAL DEVICE Generic Device Name: FACET SCREW Proprietary Device Name: FACET COMPRESSION DEVICE Registered Establishment Name: TRIAGE MEDICAL, INC.. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES OF REAMER GUIDES Proprietary Device Name: MULTIPLE TYPES OF REAMER GUIDES Registered Establishment Name: NORRIS PRECISION MANUFACTURING. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: FIXATION SCREW Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: TEMPLATE Generic Device Name: MENISCAL TRIAL, TIBIAL TRIAL, FEMORAL TRIAL, PATELLA TRIAL Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: CHAMFER BLOCK, SIZER, REMOVING INSTRUMENT, HEXDRIVER, CLAMP Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: BIT, DRILL Generic Device Name: BROACHING DRILL, LUG HOLE DRILL, LUG DRILL, DRILL BIT Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: IMPACTOR Generic Device Name: FEMORAL IMPACTOR, TIBIAL IMPACTOR Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: GUIDE PIN AND VARIOUS ARTHROSCOPIC ACCESSORIES Proprietary Device Name: MULTIPLE BRANDS ARTHROSCOPIC ACCESSORIES Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: SCREWDRIVER Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: FIXATION SCREW Proprietary Device Name: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC, MULTIPLE BRANDS Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: BROACH Generic Device Name: TIBIAL BROACH, BROACH HANDLE Proprietary Device Name: MULTIPLE Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: ACTIVE KNEE CEMENTED SYSTEM Proprietary Device Name: ACTIVE KNEE SYSTEM Registered Establishment Name: AUSTRALIAN SURGICAL DESIGN & MANUFACTURERS. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: STERILE FEMORAL COMPONENT OF UNICOMPARTMENTAL PARTIAL KNEE JOINT REPLACEMENT PRO Proprietary Device Name: BIOMET MERCK,OXFORD UNICOMPARTMENTAL KNEE Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: STERILE TOTAL KNEE JOINT REPLACEMENT PROSTHESIS FOR REVISION SURGERY Proprietary Device Name: BIOMET MERCK, AGC REVISION KNEE Registered Establishment Name: BIOMET UK LTD.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENTS FOR USE IN ORTHOPEDIC SURGERY Proprietary Device Name: BIOMET MERCK Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: STERILE TOTAL HIP JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, STANMORE HIP, SHP HIP Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: STERILE RADIAL HEAD REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: STERILE RESURFACING SHOULDER JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, COPELAND SHOULDER Registered Establishment Name: BIOMET UK LTD.. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: STERILE TOTAL ELBOW JOINT REPLACEMENT PROSTHESIS Proprietary Device Name: BIOMET MERCK, IBP ELBOW Registered Establishment Name: BIOMET UK LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SAVER MED INTL. Registered Establishment Name: SAVER MED INTL.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: BENDING OR CONTOURING INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: TUMED SURGICAL INSTRUMENTS & HOSPITAL SUPPLIES GMB. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: AWL Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: NAIL, FIXATION, BONE, METALLIC Generic Device Name: NAIL, FIXATION, BONE, METALLIC Proprietary Device Name: NAIL, FIXATION, BONE, METALLIC Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC Generic Device Name: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC Proprietary Device Name: SCREW, FIXATION, BONE, NON-SPINAL, METALLIC Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: STAPLE, FIXATION, BONE, METALLIC Generic Device Name: STAPLE, FIXATION, BONE, METALLIC Proprietary Device Name: STAPLE, FIXATION, BONE, METALLIC Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: TAP, BONE Generic Device Name: TAP, BONE Proprietary Device Name: TAP, BONE Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: BRACE, DRILL Generic Device Name: BRACE, DRILL Proprietary Device Name: BRACE, DRILL Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Generic Device Name: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Proprietary Device Name: INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: APPLIER, CERCLAGE Generic Device Name: APPLIER, CERCLAGE Proprietary Device Name: APPLIER, CERCLAGE Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: GAUGE, DEPTH Generic Device Name: GAUGE, DEPTH Proprietary Device Name: GAUGE, DEPTH Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HALTER, HEAD, TRACTION Proprietary Device Name: HALTER, HEAD, TRACTION Registered Establishment Name: ZEPF MEDICAL INSTRUMENTS GMBH. |
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