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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: SCREW, FIXATION, BONE Generic Device Name: UBP SYSTEM Proprietary Device Name: UNIVERSAL BONE PLATE SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: BACFIX SYSTEM Proprietary Device Name: BACFIX SPINAL FIXATION SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: CERCLAGE, FIXATION Generic Device Name: METALLIC BONE FIXATON APPLIANCE OR CABLE Proprietary Device Name: CFIX CABLE SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: BONE FIXATION PLATE Proprietary Device Name: ACUFIX (TM) ANTERIOR CERVICAL PLATE SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: SPINAL CONCEPTS, INC. NEX-LINK SPINAL FIXATION SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: SPINAL CONCEPTS, INC. PATHFINDER Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT Proprietary Device Name: SPINAL CONCEPTS, INC. INFIX, SPINAL CONCEPTS, INC. CADENCE, AND SPINAL CONCEPTS Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: TAMP Generic Device Name: TAMP Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: CALIPER Generic Device Name: CALIPER Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: BENDER Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: TAP, BONE Generic Device Name: TAP Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: TWISTER, WIRE Generic Device Name: WIRE TWISTER Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: COMPRESSION INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: DISPENSER, CEMENT Generic Device Name: CEMENT DISPENSER Proprietary Device Name: ABBOTT SPINE, INC. SPINNAKER SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: TALON COMPRESSION HIP SCREW Proprietary Device Name: ODI ULTIMATE COMPRESSION HIP SCREW Registered Establishment Name: ORTHOPEDIC DESIGNS, INC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: PROXIMAL FEMORAL NAIL Proprietary Device Name: ODI TALON INTRAMEDULLARY HIP NAIL Registered Establishment Name: ORTHOPEDIC DESIGNS, INC.. |
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Classification: WASHER, BOLT NUT Generic Device Name: ODI 7.0MM CANNULATED SCREW SYSTEM Proprietary Device Name: ODI 7.0MM CANNULATED SCREW SYSTEM Registered Establishment Name: ORTHOPEDIC DESIGNS, INC.. |
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Classification: BIT, DRILL Generic Device Name: TOCKSYSTEM MDK-TIN Proprietary Device Name: TOCKSYSTEM MDK-TIN Registered Establishment Name: TOCKSYSTEM. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: BENDER Generic Device Name: BENDER Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: BLACKSTONE SPINAL FIXATION SYSTEM Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: BLACKSTONE SPINAL FIXATION SYSTEM Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: ROD AND SCREW SPINAL INSTRUMENTATION Proprietary Device Name: MULTIPLE Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: BLACKSTONE SPINAL FIXATION SYSTEM Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: NUCLEUS PULPOSIS EVACTUATOR SYSTEM Proprietary Device Name: NUCLEUS PULPOSIS EVACTUATOR SYSTEM Registered Establishment Name: BLACKSTONE MEDICAL, INC.. |
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Classification: DYNAMOMETER, NONPOWERED Generic Device Name: HAND GRASP, NON-INSTRUMENTED MANIPULATION TEST Proprietary Device Name: GRASP RELEASE TEST KIT Registered Establishment Name: NEUROCONTROL CORP.. |
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Classification: CALIPER Generic Device Name: CALIPER/ORCHOMETER Proprietary Device Name: SEAGER CALIPER/ORCHOMETER Registered Establishment Name: S. SEAGER. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: HIP REPLACEMENT SYSTEM Proprietary Device Name: SIGNAL HIP SYSTEM Registered Establishment Name: SIGNAL MEDICAL CORP.. |
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