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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: BONE MILL Generic Device Name: BIO COMP MINI MILL Proprietary Device Name: BIO COMP MINI MILL Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: ROD, FIXATION, INTRAMEDULLARY Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: SCREWDRIVER Generic Device Name: ORTHOPEDIC SCREWDRIVER Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: TAP, BONE Generic Device Name: TAP, BONE Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES OF CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILLS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: FILE Generic Device Name: VARIOUS TYPES OF FILES Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF KNIVES Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF NEEDLES Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: STRIPPER, SURGICAL Generic Device Name: VARIOUS TYPES OF STRIPPERS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS TYPES OF WIRE Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF WIRE Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Generic Device Name: CONDYLAR FIXATION DEVICE Proprietary Device Name: BERARDUCCI CONDYLAR POSITION SET Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: WALTER LORENZ SURGICAL, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: BUCKS TRACTION; TRACTION UNIT, BED, OVER DOOR Proprietary Device Name: APPARATUS, TRACTION, NON-POWERED Registered Establishment Name: SCOTT SPECIALTIES, INC.. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Proprietary Device Name: PELVIC TRACTION BELT Registered Establishment Name: SCOTT SPECIALTIES, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES AND MODELS OF PERSONAL GROOMING SCISSORS Proprietary Device Name: VARIOUS TYPES AND MODELS OF PERSONAL GROOMING SCISSORS Registered Establishment Name: BILL CLARK CO.. |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: BARNES FEMORAL LENGTHENING DEVICE Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: PIEDMONT SPORTS MEDICINE COMPLEX. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE SHEATH, CANNULA, OR SLEEVE Proprietary Device Name: HIGH FLOW ARTHROSHEATH Registered Establishment Name: FUTURE MEDICAL SYSTEMS, INC.. |
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Classification: PROBE Generic Device Name: ARTHROSCOPIC PROBE Proprietary Device Name: FMS PROBE Registered Establishment Name: FUTURE MEDICAL SYSTEMS, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: TOTAL KNEE SYSTEM Proprietary Device Name: EXACTECH CEMENTED TOTAL KNEE SYSTEM Registered Establishment Name: EXACTECH, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: GAUGE, DEPTH Proprietary Device Name: GAUGE, DEPTH Registered Establishment Name: EXACTECH, INC.. |
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Classification: REAMER Generic Device Name: REAMER Proprietary Device Name: REAMER Registered Establishment Name: EXACTECH, INC.. |
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Classification: BROACH Generic Device Name: BROACH Proprietary Device Name: BROACH Registered Establishment Name: EXACTECH, INC.. |
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Classification: BIT, DRILL Generic Device Name: BIT, DRILL Proprietary Device Name: BIT, DRILL Registered Establishment Name: EXACTECH, INC.. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: EXTRACTOR Registered Establishment Name: EXACTECH, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW, FIXATION, BONE Proprietary Device Name: SCREW, FIXATION, BONE Registered Establishment Name: EXACTECH, INC.. |
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Classification: BRACE, DRILL Generic Device Name: BRACE, DRILL Proprietary Device Name: BRACE, DRILL Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Proprietary Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Proprietary Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Registered Establishment Name: EXACTECH, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: TEMPLATE Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: CERAMIC FEMORAL HEAD COMPONENTS Proprietary Device Name: EXACTECH ZIRAMIC FEMORAL HEADS Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Proprietary Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Registered Establishment Name: EXACTECH, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Proprietary Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Registered Establishment Name: EXACTECH, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: INSTRUMENTS, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENTS Proprietary Device Name: ACCUDRIVER & ACCESSORIES & ATTACHMENTS Registered Establishment Name: EXACTECH, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: EXACTECH HIP & KNEE ORTHOPEDIC SURGICAL INSTRUMENTS Registered Establishment Name: EXACTECH, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: MODULAR DRILLS BITS Proprietary Device Name: EXACTECH STERILE MODULAR DRILL BITS Registered Establishment Name: EXACTECH, INC.. |
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