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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: STAPLE, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE FIXATION STAPLES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: SPACER, CEMENT Generic Device Name: VARIOUS TYPES OF CEMENT SPACERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: VARIOUS TYPES OF THREADED FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: VARIOUS TYPES OF UNCEMENTED METAL,POLYMER,SEMI-CONSTRAINED HIP PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE FIXATION PLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: VARIOUS TYPES OF INTRAMEDULLARY FIXATION RODS & ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES OF NON-POWERED TRACTION APPARATUS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: DISPENSER, CEMENT Generic Device Name: VARIOUS TYPES OF CEMENT DISPENSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: VARIOUS TYPES OF METAL COMPOSITE MULTICOMP,NAIL,BLADE,BLADE FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Generic Device Name: VARIOUS TYPES OF SINGLE COMPONENT NAIL,BLADE,PLATE COMBO FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: VARIOUS TYPES OF NONDEGRADABLE SOFT TISSUE FIXATION FASTENERS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY-NEW BEDFORD. |
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Classification: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Generic Device Name: A-T ELBOW-CAP Proprietary Device Name: A-T ELBOW-CAP Registered Establishment Name: A-T SURGICAL MFG. CO., INC.. |
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Classification: REAMER Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: STERILE DISPOSABLE KNIFE Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: BIT, DRILL Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: VARIOUS SIZES Proprietary Device Name: WYMAN WASHER Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS SIZES AND STYLES Proprietary Device Name: FIXATION SCREW Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS SIZES AND STYLES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: ARTHROSCOPE SHAVER SYSTEM AND BLADES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: POWERED HAND INSTRUMENTS Proprietary Device Name: POWERED HAND INSTRUMENTS Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: DYONICS EP-1 SHAVER SYSTEM Proprietary Device Name: DYONICS EP-1 SHAVER SYSTEM Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST PADDING Proprietary Device Name: UNION SURGICAL Registered Establishment Name: UNION WADDING CO.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SURGICAL SCISSORS Proprietary Device Name: BRIMFIELD CIR CUT MICROSURGICAL SCISSORS Registered Establishment Name: ACCELLENT INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: REVISION INSTRUMENTATION Proprietary Device Name: MULTIPLE Registered Establishment Name: ACCELLENT INC.. |
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Classification: HALTER, HEAD, TRACTION Generic Device Name: HEAD TRACTION HALTERS Proprietary Device Name: CONCO TRACTION UNITS Registered Establishment Name: HARTMANN-CONCO INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: NONINVASIVE TRACTION COMPONENT Proprietary Device Name: NONINVASIVE TRACTION COMPONENT Registered Establishment Name: CORFLEX. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: NONPOWERED ORTHOPEDIC TRACTION APPARATUS & ACCESORIES Proprietary Device Name: NONPOWERED ORTHOPEDIC TRACTION APPARATUS & ACCESORIES Registered Establishment Name: CORFLEX. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: RAYLOR INSTURMENTS AND ACCESSORIES Proprietary Device Name: RAYLOR INSTURMENTS AND ACCESSORIES Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: BIODERADABLE FASTNERS Proprietary Device Name: MULTIPLE Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: SPINAL FUSION DEVICE Proprietary Device Name: MULTIPLE Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: SDI RONGEUR Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE FIXATION Proprietary Device Name: REUNION BONE SCREW SYSTEM Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: IMPACTOR Generic Device Name: MALLET Proprietary Device Name: RAYLOR MALLET Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: SPINAL PLATING SYSTEM Proprietary Device Name: AMEND PLATING SYSTEM Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: CERCLAGE, FIXATION Generic Device Name: ORTHOPEDIC POLYETHLYENE CABLE Proprietary Device Name: SECURESTRAND SYSTEM Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: SDI DEPTH GAUGE Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: ORTHOPEDIC INSTRUMENTS Proprietary Device Name: DISH WHISK Registered Establishment Name: UNITED STATES SURGICAL. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE FIXATORS Proprietary Device Name: MULTIPLE Registered Establishment Name: UNITED STATES SURGICAL. |
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