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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: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: CALCANEUS DISTRACTOR Proprietary Device Name: CALCANEUS DISTRACTOR Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: WIRE/BENDER Proprietary Device Name: WIRE/BENDER Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: BIT, DRILL Generic Device Name: BIT, DRILL Proprietary Device Name: DRILL BIT Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: INSTRUMENT, COMPRESSION Generic Device Name: INSTRUMENT, COMPRESSION Proprietary Device Name: HEEL PRESS Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: CANNULATED BONE SCREW Proprietary Device Name: EPIPHYSIS Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: BONE PLATE & BONE SCREW SYSTEM Proprietary Device Name: PILONPLATE W/ANGULAR STABILITY Registered Establishment Name: I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: SHUZRA SURGICAL COMPANY. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE Registered Establishment Name: SHUZRA SURGICAL COMPANY. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR Registered Establishment Name: SHUZRA SURGICAL COMPANY. |
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Classification: CALIPER Generic Device Name: CALIPER, CLINICAL USE Proprietary Device Name: CALIPER Registered Establishment Name: SHUZRA SURGICAL COMPANY. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: B.B.S. INTERNATIONAL. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: REHMAN QADRI CORPORATION Registered Establishment Name: REHMAN QADRI CORP.. |
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Classification: FIXATION ACCESSORY Generic Device Name: COMPONENTS FOR VARIOUS SPINAL FIXATION Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: VARIOUS COMPONENTS FOR SPINAL FIXATION(INTERVERTEBRAL BODY) Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: VARIOUS SPINAL FIXATION APPLIANCES Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: BENDER Generic Device Name: BENDING INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: TWISTER, WIRE Generic Device Name: WIRE TWISTING INSTRUMENT Proprietary Device Name: OCHSNER WIRE TWISTER Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: WRENCH Generic Device Name: SURGICAL WRENCH AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: TAP, BONE Generic Device Name: BONE TAPS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: TEMPLATE Generic Device Name: VARIOUS TEMPLATES FOR CLINICAL USE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREWS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: IMPACTOR Generic Device Name: IMPACTORS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL BITS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: KNIFE, ORTHOPEDIC Generic Device Name: STERNAL KNIFE Proprietary Device Name: LEBSCHE STERNAL KNIFE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: GAUGE, DEPTH Generic Device Name: DEPTH GUAGE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS SCISSORS FOR ORTHOPEDIC USE Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS MANUAL SURGICAL ORTHOPEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: CODMAN AND SHURTLEFF, INC.. |
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Classification: ORTHOSIS, SPINAL INTERVERTEBRAL FUSION Generic Device Name: INSTRUMENTS FOR SPINAL FUSION DEVICES Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER SPINE. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: OTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: STRYKER SPINE. |
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Classification: ANCHOR, SUTURE, BONE FIXATION, METALLIC Generic Device Name: VARIOUS TYPES OF BONE ANCHORS, VARIOUS TYPES OF BONE FIXATION Proprietary Device Name: VARIOUS TYPES OF BONE ANCHORS, VARIOUS TYPES OF BONE FIXATION Registered Establishment Name: C-AXIS P.R., INC.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST COMPONENT Proprietary Device Name: AC HEALTHCARE Registered Establishment Name: AC HEALTHCARE SUPPLY, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: EXPERIENCE SURGICAL CO. Registered Establishment Name: EXPERIENCE SURGICAL CO.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: VARIOUS TYPES OF METAL HEMI-FEMORAL HIP PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS TYPES OF POLY,METAL,CEMENTED,SEMI-CONST'D,PATELLOFEM-TIB,KNEE PROSTHESIS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF CEMENTED METAL,POLYMER,SEMI-CONSTRAINED,FEMOROTIBIAL KNEE PROST Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED Generic Device Name: VARIOUS TYPES OF CEMENTED,SEMI-CONSTRAINED,ELBOW PROSTHESES Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: VARIOUS TYPES OF METAL,POLYMER Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: VARIOUS TYPES OF CEMENTED,UNCEMENTED METAL,POLY,FEMORAL HEMI-HIP PROS Proprietary Device Name: MULTIPLE Registered Establishment Name: DEPUY BRIDGEWATER. |
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