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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: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: PRE-LOADED ANCHOR Proprietary Device Name: PRE-LOADED SOFT TISSUE ANCHOR Registered Establishment Name: LINVATEC CORP.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: ARTHOKNIFE Proprietary Device Name: ARTHOKNIFE Registered Establishment Name: LINVATEC CORP.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW, FIXATION, BONE (VARIOUS) Proprietary Device Name: MULTIPLE Registered Establishment Name: LINVATEC CORP.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: LINVATEC CORP.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: MICRO E Proprietary Device Name: MICRO E Registered Establishment Name: LINVATEC CORP.. |
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Classification: REAMER Generic Device Name: REAMER Proprietary Device Name: VARIOUS Registered Establishment Name: LINVATEC CORP.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: PIN Proprietary Device Name: C-WIRE Registered Establishment Name: LINVATEC CORP.. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: BONE STAPLE Proprietary Device Name: STAPLIZER Registered Establishment Name: LINVATEC CORP.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS TYPES OF SICISSORS AND CAST SPREADERS Proprietary Device Name: ESMARCH;HENNIG Registered Establishment Name: SAMMONS PRESTON ROLYAN. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: ROLYAN FINGER GONIOMETER, HYPER-EXTENSION, FLEXION FINGER, EDEMA TAPE Registered Establishment Name: SAMMONS PRESTON ROLYAN. |
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Classification: SPLINT, TRACTION Generic Device Name: HEAD HALTER Proprietary Device Name: VARIOUS Registered Establishment Name: SAMMONS PRESTON ROLYAN. |
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Classification: REAMER Generic Device Name: RUSH AWL REAMER #701 - #702 - #703 - #704 Proprietary Device Name: RUSH AWL REAMER Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Generic Device Name: RUSH CONDYLE PIN #250 Proprietary Device Name: RUSH CONDYLE PIN Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: EXTRACTOR Generic Device Name: RUSH PIN EXTRACTOR #762 Proprietary Device Name: RUSH PIN EXTRACTOR Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: BENDER Generic Device Name: RUSH BENDER #900 Proprietary Device Name: RUSH BENDER FOR ALL RUSH PIN Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: RUSH WIRE CARRIER #801 - #802 - #803 Proprietary Device Name: RUSH WIRE CARRIER Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: RUSH MEDULLARY PIN, SPECIAL FEMUR #100, #200, #300, #400, #500 Proprietary Device Name: RUSH MEDULLARY PIN, SPECIAL FEMUR PIN #100, #300, #400, #500 Registered Establishment Name: RUSH/BERIVON, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES OF INTERNAL FIXATION APPLIANCES & ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: PIN Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTRAMEDULLARY NAIL Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: NAIL Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: EXTERNAL FIXATION DEVICE Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: K-WIRE, STEINMAN PIN Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: WASHER, BOLT NUT Generic Device Name: WASHER, BOLT, NUT Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Generic Device Name: NAIL/BLADE/PLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: PLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: EXTERNAL FIXATION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER TRAUMA AG. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: EVACUATOR, VAPOR, CEMENT MONOMER Generic Device Name: VARIOUS TYPES OF CEMENT MONOMER VAPOR EVACUATORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: CALIPER Generic Device Name: VARIOUS TYPES OF CALIPERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF NONPOWERED GONIOMETERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: DISPENSER, CEMENT Generic Device Name: VARIOUS TYPES OF CEMENT DISPENSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF ANKLE PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER Generic Device Name: VARIOUS TYPES OF ELBOW PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED Generic Device Name: VARIOUS TYPES OF WRIST PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: VARIOUS TYPES OF CEMENT MIXERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS TYPES OF PNEUMATIC POWERED SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SMITH & NEPHEW, INC.. |
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