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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/POLYMER, UNCEMENTED Generic Device Name: ARTIFICIAL HIP REPLACEMENT COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: ARTIFICIAL HIP REPLACEMENT COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: ARTIFICIAL KNEE REPLACEMENT COMPONENTS Proprietary Device Name: PROVEN Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER IMPLANT Proprietary Device Name: EPOCA CUSTOM OFFSET SHOULER SYSTEM Registered Establishment Name: STELKAST COMPANY. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: UNICONDYLAR KNEE SYSTEM Proprietary Device Name: STELKAST UNICONDYLAR KNEE SYSTEM Registered Establishment Name: STELKAST COMPANY. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: BUKHARI TRADE ASSOCIATES Registered Establishment Name: BUKHARI TRADE ASSOCIATE. |
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Classification: TAMP Generic Device Name: VARIOUS TYPES OF BONE TAMPER Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF NEEDLE HOLDER Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: WIRE, SURGICAL Generic Device Name: VARIOUS TYPES OF CERCLAGE Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES OF WIRE CUTTER Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF INSTRUMENT Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: STRIPPER, SURGICAL Generic Device Name: VARIOUS TYPES OF STRIPPER Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES OF GONIOMETER Proprietary Device Name: NONE Registered Establishment Name: BUXTON BIOMEDICAL, INC.. |
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Classification: PROBE Generic Device Name: PROBES/EXCAVATORS Proprietary Device Name: PROBES/EXCAVATORS Registered Establishment Name: SOLATCH SONS. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: STARMED ENGINEERING (PVT) LTD.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF DRILLS Proprietary Device Name: BIT, DRILL Registered Establishment Name: STARMED ENGINEERING (PVT) LTD.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: VARIOUS TYPES OF BONE NAILS Proprietary Device Name: NONE Registered Establishment Name: STARMED ENGINEERING (PVT) LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS (MULTIPLE BRANDS) Registered Establishment Name: STARMED ENGINEERING (PVT) LTD.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: VARIOUS SIZES OF CANCELLOUS BONE SCREWS Proprietary Device Name: CANCELLOUS BONE SCREW Registered Establishment Name: SYNTHES (USA). |
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Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: VARIOUS TYPES AND SIZES OF PNEUMATIC ACCESSORIES AND ATTACHMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES AND SIZES OF NON-POWERED,APPARATUS,TRACTIONS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PROTRACTOR Generic Device Name: VARIOUS TYPES AND SIZES OF PROTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: BROACH Generic Device Name: VARIOUS TYPES AND SIZES OF BROACHES Proprietary Device Name: BROACH Registered Establishment Name: SYNTHES (USA). |
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Classification: REAMER Generic Device Name: VARIOUS TYPES AND SIZES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: PROBE Generic Device Name: VARIOUS TYPES AND SIZES PROBES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: AWL Generic Device Name: VARIOUS TYPES AND SIZES OF AWLS Proprietary Device Name: AWL Registered Establishment Name: SYNTHES (USA). |
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Classification: EXTRACTOR Generic Device Name: VARIOUS TYPES AND SIZES OF EXTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES AND SIZES OF ORTHOPAEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERVERTEBRAL,FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL INTERLAMINAL FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: VARIOUS TYPES SIZES OF NONPOWERED GONIOMETERS Proprietary Device Name: GONIOMETER Registered Establishment Name: SYNTHES (USA). |
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Classification: STARTER, BONE SCREW Generic Device Name: VARIOUS TYPES AND SIZES OF BONE SCREW STARTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES AND SIZES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: VARIOUS Proprietary Device Name: HYBRID EXTERNAL FIXATOR Registered Establishment Name: SYNTHES (USA). |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: TAP, BONE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: IMPACTOR Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES (USA). |
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Classification: COUNTERSINK Generic Device Name: VARIOUS TYPES AND SIZES OF COUNTERSINKS Proprietary Device Name: COUNTERSINK (MULTIPLE BRANDS) Registered Establishment Name: SYNTHES (USA). |
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