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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, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: TEMPORARY HIP SPACER Proprietary Device Name: INTERSPACE HIP Registered Establishment Name: TECRES SPA. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: TEMPORARY KNEE SPACER Proprietary Device Name: SPACER, INTERSPACE KNEE Registered Establishment Name: TECRES SPA. |
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Classification: BONE CEMENT, ANTIBIOTIC Generic Device Name: BONE CEMENT WITH GENTAMICIN Proprietary Device Name: CEMEX SYSTEM GENTA Registered Establishment Name: TECRES SPA. |
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Classification: CEMENT, BONE, VERTEBROPLASTY Generic Device Name: POLYMETHYLMETHACRYLATE;PMMA;ACRYLIC RESIN FOR VERTEBROPLASTY Proprietary Device Name: MENDEC SPINE Registered Establishment Name: TECRES SPA. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: ARTIFICIAL HIP REPLACEMENT COMPONET Proprietary Device Name: ARGOMEDICAL BIPOLAR Registered Establishment Name: ARGOMEDICAL AG. |
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Classification: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: SHOULDER IMPLANT Proprietary Device Name: EPOCA CUSTOM OFFSET SHOULDER SYSTEM Registered Establishment Name: ARGOMEDICAL AG. |
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Classification: AWL Generic Device Name: AWL Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: BIT, DRILL Generic Device Name: DRILL BIT Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS MANUAL ORTHOPEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: TAP, BONE Generic Device Name: VARIOUS BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS SPINAL INTERLAMINAL FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: WRENCH Generic Device Name: VARIOUS WRENCHES Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GAUGE Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT DEVICE Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: VARIOUS SPINAL IMPLANT FIXATION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: BENDER Generic Device Name: ROD AND PLATE BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCIENT'X. |
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Classification: PROBE Generic Device Name: VARIOUS PROBES DENTAL DISPOSABLE Proprietary Device Name: MULTIPLE PROBES DENTAL DISPOSABLE Registered Establishment Name: KENCAP LTD.. |
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Classification: SPLINT, TRACTION Generic Device Name: ACCESSORY TO A TRACTION SPLINT Proprietary Device Name: UNIVERSAL TRACTION HARNESS Registered Establishment Name: RESCUE SPECIALISTS, INC.. |
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Classification: SCREWDRIVER Generic Device Name: VARIOUS TYPES OF SCREWDRIVERS Proprietary Device Name: MULTIPLE Registered Establishment Name: UDO SCHILLING CNC-DREHTEILE. |
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Classification: TAP, BONE Generic Device Name: TAP, BONE Proprietary Device Name: TAP, BONE Registered Establishment Name: UDO SCHILLING CNC-DREHTEILE. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: CERVICAL ANTERIOR FIXATION PLATING SYSTEM Proprietary Device Name: TOP CERVICAL STABILIZATION SYSTEM Registered Establishment Name: FEHLING INSTRUMENTS, GMBH. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: FEHLING INSTRUMENTS, GMBH. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: ARTHROSCOPE Registered Establishment Name: JURGEN B. LINDEMAN. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS Proprietary Device Name: DRILL; INTRODUCER TOOL SET (COMPONENT) Registered Establishment Name: KYPHON, INC.. |
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Classification: DISPENSER, CEMENT Generic Device Name: VARIOUS Proprietary Device Name: BONE VOID FILLER TOOLS Registered Establishment Name: KYPHON, INC.. |
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Classification: TAMP Generic Device Name: VARIOUS TYPES OF STERILE, INFLATABLE BONE TAMPS Proprietary Device Name: KYPHX INFLATABLE BONE TAMP Registered Establishment Name: KYPHON, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: CURETTE Proprietary Device Name: KYPHX LATITUDE CURETTE DEVICE Registered Establishment Name: KYPHON, INC.. |
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Classification: CEMENT, BONE, VERTEBROPLASTY Generic Device Name: STERILE POLYMETHYLMETHACRYLATE, PMMA, BONE CEMENT Proprietary Device Name: KYPHX HV-R BONE CEMENT Registered Establishment Name: KYPHON, INC.. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: CEMENT MIXER Proprietary Device Name: KYPHON MIXER Registered Establishment Name: KYPHON, INC.. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: INCLINOMETER, ANGLE FINDER Proprietary Device Name: UNI LEVEL INCLINOMETER Registered Establishment Name: ISOMED,INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: MEDICAL INSTRUMENTS RELY CORP.. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE Registered Establishment Name: MEDICAL INSTRUMENTS RELY CORP.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL FIXATION DEVICE SYSTEM Proprietary Device Name: MICOMED POSTERIOR DOUBLEROD SYSTEM Registered Establishment Name: MICOMED ORTHO GMBH. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION DEVICE SYSTEM Proprietary Device Name: HALM ZIELKE INSTRUMENTATION SYSTEM Registered Establishment Name: MICOMED ORTHO GMBH. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL FIXATION DEVICE SYSTEM Proprietary Device Name: MICOMED POSTERIOR DOUBLEROD SYSTEM Registered Establishment Name: MICOMED ORTHO GMBH. |
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