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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, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM Proprietary Device Name: SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: COCR FEMORAL HEAD AND TITANIUM STEM Proprietary Device Name: QUATROLOC FEMORAL COMPONENT AND HEAD Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: BIPOLAR FEMORAL HEAD Proprietary Device Name: BIPOLAR FEMORAL HEAD Registered Establishment Name: WHITESIDE BIOMECHANICS, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL INTERVERTEBRAL STABILIZATION DEVICE Proprietary Device Name: TOP SPINAL PLATE AND SCREWS Registered Establishment Name: FEHLING SURGICAL INSTRUMENTS, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE FIXATION PLATES, VARIOUS TYPES Proprietary Device Name: MULTIPLE AAP BONE PLATES, APS HIP PLATES Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR, VARIOUS TYPES Proprietary Device Name: MULTIPLE, AAP IMPACTOR, APS IMPACTOR Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: WRENCH Generic Device Name: WRENCHES, VARIOUS TYPES Proprietary Device Name: MULTIPLE, AAP WRENCH, APS DRIVING WRENCH Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: AAP COMPRESSION DEVICE Proprietary Device Name: AAP COMPRESSION DEVICE Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: TAP, BONE Generic Device Name: VARIOUS TYPES OF BONE TAPS Proprietary Device Name: MULTIPLE-AAP TAP, APS TAP Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: GAUGE, DEPTH Generic Device Name: AAP DEPTH GAUGE Proprietary Device Name: AAP DEPTH GAUGE Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES OF REAMERS Proprietary Device Name: MULTIPLE AAP REAMER, APS DRILL REAMER Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS SIZES OF DRILL BITS Proprietary Device Name: AAP TWIST DRILL Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: SCREWDRIVER Generic Device Name: ORTHOPEDIC SCREWDRIVERS - VARIOUS TYPES Proprietary Device Name: MULTIPLE Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: CANNULATED BONE SCREWS Proprietary Device Name: AAP CANNULATED SCREWS Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: BIORIGID FEMORAL NAIL SYSTEM Proprietary Device Name: AAP BIORIGID NAIL FEMUR Registered Establishment Name: AAP IMPLANTATE AG. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: VARIOUS TYPES OF FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: HOFMANN S.R.L.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: HOFMANN S.R.L.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: VARIOUS TYPES OF SMOOTH FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOFMANN S.R.L.. |
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Classification: PIN, FIXATION, SMOOTH, METALLIC Generic Device Name: VARIOUS TYPES OF FIXATION PINS Proprietary Device Name: MULTIPLE Registered Establishment Name: HOFMANN S.R.L.. |
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Classification: BIT, DRILL Generic Device Name: ARTHRODESIS SET Proprietary Device Name: REESE ARTHRODESIS SCREW SYSTEM Registered Establishment Name: PHOENIX SURGICAL PRODUCTS, INC.. |
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Classification: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Generic Device Name: VARIOUS Proprietary Device Name: MULTITAK SS SUTURE SYSTEM Registered Establishment Name: BONUTTI RESEARCH, INC.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS Proprietary Device Name: MULTITAK SS SUTURE SYSTEM Registered Establishment Name: BONUTTI RESEARCH, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: MULTITAK SS SUTURE SYSTEM Registered Establishment Name: BONUTTI RESEARCH, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: MULTIPLE Registered Establishment Name: MICROMA MARTIN ALBER GMBH & CO. KG. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPES Proprietary Device Name: FLEXILUX II (ARTHROSCOPES AND ACCESSORIES) Registered Establishment Name: SCHOELLY FIBEROPTIC, GMBH. |
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Classification: REAMER Registered Establishment Name: TL TATE MFG, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: ST 360 SPINAL FIXATION SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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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: ZIMMER SPINE, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: LAPAROSCOPIC SPINAL FUSION INSTRUMENTATION Proprietary Device Name: SPINE-TECH LAPAROSCOPIC INSTRUMENT SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY Generic Device Name: SPINAL FIXATION PLATES AND SCREWS Proprietary Device Name: CERVI-LOK SPINAL FIXATION SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS LAPAROSCOPIC SPINAL FUSION INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: REAMER Generic Device Name: REAMER Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: COMPRESSION INSTRUMENT Proprietary Device Name: COMPRESSOR Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: MULTIPLE Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: CERVICAL BONE IMPACTOR Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Proprietary Device Name: CERVI-LOCK SPINAL FIXATION SYSTEM, TRINICA/TRINICA SELECT ANTERIOR CERVICAL PLAT Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: INTERBODY FUSION CAGE Proprietary Device Name: BP CAGE, BP LORDOTIC INTERBODY FUSION SYSTEM, BAR INTERBODY FUSION SYSTEM, PROXI Registered Establishment Name: ZIMMER SPINE, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPONDYLOISTHESIS SPINAL FIXATION SYSTEM Proprietary Device Name: SIHOUETTE SPINAL FIXATION SYSTEM, ST 360 SPINAL FIXATION SYSTEM Registered Establishment Name: ZIMMER SPINE, INC.. |
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