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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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: INTERVERTEBRAL SPACER DISTRACTION SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER SPINE. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: GOLDSTAR MEDICAL INSTRUMENTS. Registered Establishment Name: GOLDSTAR MEDICAL INSTRUMENTS. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES AND SIZES OF MANUAL ORTHOPEDIC SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES AND SIZES OF MULTIPLE COMPONENT MAIL/BLADE/PLATE/APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: VARIOUS TYPES AND SIZES OF TRACTION COMPONENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES AND SIZES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: BENDER Generic Device Name: VARIOUS TYPES AND SIZES OF BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS TYPES AND SIZES OF TWISTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: VARIOUS TYPES AND SIZES OF BENDING INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: WRENCH Generic Device Name: VARIOUS TYPES AND SIZES OF WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: TAP, BONE Generic Device Name: VARIOUS TYPES AND SIZES OF TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: TEMPLATE Generic Device Name: VARIOUS TYPES AND SIZES OF TEMPLATES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: AWL Generic Device Name: VARIOUS TYPES AND SIZES OF AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS TYPES AND SIZES OF EXTRACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES AND SIZES OF BITS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: BURR, ORTHOPEDIC Generic Device Name: VARIOUS TYPES AND SIZES OF BURRS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES AND SIZES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: GAUGE, DEPTH Generic Device Name: VARIOUS TYPES AND SIZES OF GUAGES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES AND SIZES OF TRACTION APPARATUSES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Generic Device Name: VARIOUS TYPES AND SIZES OF SPINAL PEDICLE FIXATION ORTHOSES FOR DEGENERATIVE DI Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: IMPACTOR Generic Device Name: VARIOUS TYPES AND SIZES OF IMPACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: TREPHINE Generic Device Name: VARIOUS TYPES AND SIZES OF TREPHINES Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: VARIOUS TYPES AND SIZES OF COMPRESSION INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES HAGENDORF GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: ESS ZEE INDUSTRIES Registered Establishment Name: ESS ZEE INDUSTRIES. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: ESS - ZEE INDUSTRIES Registered Establishment Name: ESS ZEE INDUSTRIES. |
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Classification: STARTER, BONE SCREW Generic Device Name: BONE SCREW Proprietary Device Name: ESS-ZEE INDUSTRIES Registered Establishment Name: ESS ZEE INDUSTRIES. |
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Classification: SCREWDRIVER Generic Device Name: SCREW DRIVER Proprietary Device Name: ESS-ZEE INDUSTRIES Registered Establishment Name: ESS ZEE INDUSTRIES. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE VOID FILLERS Proprietary Device Name: MULTIPLE Registered Establishment Name: THERICS, LLC. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR,DIVER, INTRODUCER Proprietary Device Name: IMPACTOR Registered Establishment Name: FIVE STAR MEDICAL DEVICES INC.. |
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Classification: FILLER, BONE VOID, CALCIUM COMPOUND Generic Device Name: BONE VOID FILLER Proprietary Device Name: CALLOS Registered Establishment Name: SKELETAL KINETICS, LLC. |
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Classification: DISPENSER, CEMENT Generic Device Name: SYRINGE Proprietary Device Name: CALLOS CEMENT DELIVERY SYSTEM Registered Establishment Name: SKELETAL KINETICS, LLC. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: KNEE EXTENSION BOARD Proprietary Device Name: APPARATUS, TRACTION, NON-POWERED#ORTHOPEDIC Registered Establishment Name: TOP SHELF MANUFACTURING, LLC. |
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Classification: EXTRACTOR Generic Device Name: VARIOUS ORTHOPEDIC SURGICAL INSTRUMENTS Proprietary Device Name: SURGICAL INSTRUMENTS Registered Establishment Name: SMB SA. |
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Classification: PROSTHESIS, WRIST, HEMI-, ULNAR Generic Device Name: DISTAL ULNA Proprietary Device Name: DRUJ Registered Establishment Name: APTIS MEDICAL, LLC.. |
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Classification: PROSTHESIS, WRIST, CARPAL SCAPHOID Generic Device Name: SCAPHOID STERILE IMPLANT Proprietary Device Name: APSI Registered Establishment Name: BIOPROFILE. |
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Classification: PROBE Generic Device Name: DENTAL PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: DENTAL USA, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: DENTAL SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: DENTAL USA, INC.. |
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Classification: RONGEUR Generic Device Name: DENTAL RONGEUR Proprietary Device Name: MULTIPLE Registered Establishment Name: DENTAL USA, INC.. |
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Classification: CALIPER Generic Device Name: CALIPER Proprietary Device Name: MULTIPLE Registered Establishment Name: DENTAL USA, INC.. |
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