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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: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: SPINAL FIXATION SYSTEM, MULTIPLE Registered Establishment Name: ENDIUS, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SYSTEM Proprietary Device Name: SPINAL FIXATION SYSTEM, MULTIPLE Registered Establishment Name: ENDIUS, INC.. |
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Classification: COMPONENT, TRACTION, NON-INVASIVE Generic Device Name: SHOULDER TRAC Proprietary Device Name: SHOULDER TRAC Registered Establishment Name: CIMEX BIOTECH, LLC.. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: CORTICAL BONE SCREW Proprietary Device Name: LOW PROFILE CORTICAL BONE SCREW Registered Establishment Name: TRIMED, INC.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: SMALL FRAGMENT PLATE Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIMED, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SMALL FRAGMENT FIXATION SYSTEM Proprietary Device Name: MULTIPLE Registered Establishment Name: TRIMED, INC.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE FOR CLINICAL USE Proprietary Device Name: S.A.F.E. MEDICAL OSTEOTOMY GUIDES Registered Establishment Name: S.A.F.E. MEDICAL PRODUCTS, L.L.C.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDICS INSTRUMENTS Proprietary Device Name: VARIOUS Registered Establishment Name: PLUS ORTHOPEDICS USA, INC.. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: A NON-POWERED ORTHOPEDIC TRACTION APPARATUS Proprietary Device Name: BACK BUBBLE Registered Establishment Name: BACK BUBBLE. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: TATA SERVICES Registered Establishment Name: TATA SERVICES. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE Proprietary Device Name: MR COMPATIBLE ARTHROSCOPE AND SMALL JOINT ARTHROSCOPE Registered Establishment Name: MINRAD, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS Proprietary Device Name: TMJ FIXATION INSTRUMENTS Registered Establishment Name: TMJ SOLUTIONS, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH Generic Device Name: MRP-TITAN Proprietary Device Name: MRP-TITAN Registered Establishment Name: PETER BREHM GMBH CHIRUGIE MECHANIK. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: MRS-TITAN Proprietary Device Name: MRS-TITAN Registered Establishment Name: PETER BREHM GMBH CHIRUGIE MECHANIK. |
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Classification: CALIPER Generic Device Name: CALIPERS FOR CLINICAL USE Proprietary Device Name: MULTIPLE Registered Establishment Name: GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.. |
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Classification: ARTHROSCOPE Generic Device Name: ARTHROSCOPE AND ACCESSORIES Proprietary Device Name: MULTIPLE Registered Establishment Name: ANTJE TONTARRA. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: PAMEXLAND INTERNATIONAL Registered Establishment Name: PAMEXLAND INTERNATIONAL. |
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Classification: AWL Generic Device Name: VARIOUS TYPES OF AWL Proprietary Device Name: MULTIPLE Registered Establishment Name: DCV INSTRUMENTE GMBH. |
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Classification: PROBE Generic Device Name: VARIOUS TYPES OF PROBES Proprietary Device Name: MULTIPLE Registered Establishment Name: DCV INSTRUMENTE GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS Registered Establishment Name: HUMERA SANKYO CORPORATION. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: PLASTIC HANDLE SCISSORS Proprietary Device Name: LONJYFAN PLASTIC HANDLE SCISSORS Registered Establishment Name: LONJYFAN ENTERPRISE CORP.. |
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Classification: TAP, BONE Generic Device Name: TAP SLEEVE Proprietary Device Name: TAP, BONE (MULTIPLE BRANDS) Registered Establishment Name: OTTO LEIBINGER GMBH. |
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Classification: TAMP Generic Device Name: BONE TAMP Proprietary Device Name: TAMP (MULTIPLE BRANDS) Registered Establishment Name: OTTO LEIBINGER GMBH. |
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Classification: IMPACTOR Generic Device Name: GRAFT IMPACTOR Proprietary Device Name: MULTIPLE, VARIOUS Registered Establishment Name: OTTO LEIBINGER GMBH. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ABLE BROTHERS. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: GONIOMETER Proprietary Device Name: ROLIMETR Registered Establishment Name: AIRCAST LLC. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: COMPRESSION HIP SCREW SYSTEM Proprietary Device Name: VHS- VARI-ANGLE HIP SYSTEM Registered Establishment Name: IMPLANT DISTRIBUTION NETWORK, LTD.. |
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Classification: COMPONENT, CAST Generic Device Name: CAST PROTECTOR OR SUPPORTER Proprietary Device Name: VARIOUS SIZES OF CAST WALKER KIT Registered Establishment Name: HEALTH CARE LOGISTICS, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: COMPRESSION HIP NAIL Proprietary Device Name: SLIM GLIDING NAIL SYSTEM Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: UNICONDYLAR KNEE Proprietary Device Name: UC-PLUS SOLUTION KNEE Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Generic Device Name: INTRAMEDULLARY FIXATION ROD Proprietary Device Name: IP-XS COMPRESSION NAIL SYSTEM Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: HEMI OR TOTAL SHOULDER - HUMERAL Proprietary Device Name: PROMOS SHOULDER Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Generic Device Name: HEMI OR TOTAL SHOULDER - GLENOIDS & BALL HEADS Proprietary Device Name: PROMOS SHOULDER Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREWS - VARIOUS SIZES Proprietary Device Name: PLUS CANCELLOUS BONE SCREW Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Generic Device Name: ALL PE ACETABULAR CUPS, CEMENTED HIP STEMS Proprietary Device Name: PE - PLUS ACETABULAR CUP, PLUS ORTHOPEDICS CEMENTED HIP STEM Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: VARIOUS SIZES & COMPONENTS OF TOTAL KNEE PROSTHESIS Proprietary Device Name: TC-PLUS SOLUTION KNEE, VKS KNEE SYSTEM, VKS/TC-PLUS REVISION KNEE Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Generic Device Name: ROTATING HINGE KNEE SYSTEM Proprietary Device Name: RT-PLUS SOLUTION KNEE SYSTEM Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Generic Device Name: UNIPOLAR HEAD Proprietary Device Name: PLUS UNIPOLAR HEAD, PLUS FRACTURE HEAD Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Generic Device Name: BIPOLAR HEAD Proprietary Device Name: PLUS BIPOLAR HEAD Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: PLUS MANUAL SURGICAL INSTRUMENTS Registered Establishment Name: PLUS ORTHOPEDICS AG. |
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