 |
|||||||
US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
|||||||
|
|||||||
|
|
|||||||
US Food and Drug Administration (FDA) - Orthopedic Devices Registration |
|||||||
|
|||||||
| First Page | Previous Page | Next Page | Last Page |
|
Classification: CUTTER, WIRE Generic Device Name: CUTTER, WIRE Proprietary Device Name: WIRE CUTTER Registered Establishment Name: PRECIMED SA.. |
|
Classification: GUIDE, DRILL, LIGAMENT Generic Device Name: DRILL GUIDE Proprietary Device Name: DRILL GUIDE Registered Establishment Name: PRECIMED SA.. |
|
Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: FLEXIBLE SHAFT Proprietary Device Name: PRECIFAR / PRECIMED Registered Establishment Name: PRECIMED SA.. |
|
Classification: REAMER Generic Device Name: VARIOUS Proprietary Device Name: PRECIFAR / PRECIMED REAMER Registered Establishment Name: PRECIMED SA.. |
|
Classification: BIT, DRILL Generic Device Name: VARIOUS Proprietary Device Name: PRECIFAR / PRECIMED DRILL Registered Establishment Name: PRECIMED SA.. |
|
Classification: DRIVER, PROSTHESIS Generic Device Name: ANGLED DRIVER Proprietary Device Name: PRECIFAR / PRECIMED DRIVER Registered Establishment Name: PRECIMED SA.. |
|
Classification: TAP, BONE Generic Device Name: BONE TAP Proprietary Device Name: BONE TAP Registered Establishment Name: PRECIMED SA.. |
|
Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: SCREWDRIVER Registered Establishment Name: PRECIMED SA.. |
|
Classification: BURR, ORTHOPEDIC Generic Device Name: BURR Proprietary Device Name: BURR Registered Establishment Name: PRECIMED SA.. |
|
Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: GUIDE WIRE Proprietary Device Name: GUIDE WIRE Registered Establishment Name: PRECIMED SA.. |
|
Classification: BENDER Generic Device Name: WIRE BENDER Proprietary Device Name: WIRE BENDER Registered Establishment Name: PRECIMED SA.. |
|
Classification: GAUGE, DEPTH Generic Device Name: DEPH GAUGE Proprietary Device Name: DEPH GAUGE Registered Establishment Name: PRECIMED SA.. |
|
Classification: COUNTERSINK Generic Device Name: COUNTERSINK Proprietary Device Name: COUNTERSINK Registered Establishment Name: PRECIMED SA.. |
|
Classification: PLATE, FIXATION, BONE Generic Device Name: PLATE, FIXATION, BONE Proprietary Device Name: PLATE Registered Establishment Name: PRECIMED SA.. |
|
Classification: BROACH Generic Device Name: BROACH Proprietary Device Name: BROACH Registered Establishment Name: PRECIMED SA.. |
|
Classification: IMPACTOR Generic Device Name: IMPACTOR Proprietary Device Name: IMPACTOR Registered Establishment Name: PRECIMED SA.. |
|
Classification: EXTRACTOR Generic Device Name: EXTRACTOR Proprietary Device Name: EXTRACTOR Registered Establishment Name: PRECIMED SA.. |
|
Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW, FIXATION, BONE Proprietary Device Name: SCREW Registered Establishment Name: PRECIMED SA.. |
|
Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: TEMPLATE Registered Establishment Name: PRECIMED SA.. |
|
Classification: WRENCH Generic Device Name: WRENCH Proprietary Device Name: WRENCH Registered Establishment Name: PRECIMED SA.. |
|
Classification: TWISTER, WIRE Generic Device Name: TWISTER, WIRE Proprietary Device Name: WIRE TWISTER Registered Establishment Name: PRECIMED SA.. |
|
Classification: BRACE, DRILL Generic Device Name: BRACE, DRILL Proprietary Device Name: DRILL BRACE Registered Establishment Name: PRECIMED SA.. |
|
Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MANUAL INSTRUMENT Registered Establishment Name: PRECIMED SA.. |
|
Classification: CUTTER, WIRE Generic Device Name: REPLACEMENT PARTS FOR WIRE CUTTERS Proprietary Device Name: REPLACEMENT PARTS FOR WIRE CUTTERS Registered Establishment Name: DANNORITZER MEDIZINTECHNIK GMBH & CO. KG. |
|
Classification: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT Generic Device Name: PNEUMATIC POWERED ORTHOPEDIC INSTRUMENT Proprietary Device Name: IMT PNEUMATIC RASP Registered Establishment Name: PLUS ORTHOPEDICS AG. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREWS - VARIOUS SIZES Proprietary Device Name: PLUS CANCELLOUS BONE SCREW Registered Establishment Name: PLUS ORTHOPEDICS AG. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
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. |
|
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: VARIOUS SIZES & DESIGNS OF FEMORAL HIP STEMS Proprietary Device Name: UNI-STEM HIP PROSTHESIS, MODULAR PLUS REVISION STEMS, SL-PLUS LATERALIZED STEMS Registered Establishment Name: PLUS ORTHOPEDICS AG. |
|
Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED Generic Device Name: VARIOUS SIZES & DESIGNS OF ACETABULAR CUPS, INSERTS AND BALL HEADS Proprietary Device Name: BOFOR REVISION CUP, MPF ACETABULAR CUPS GEN II, MPF ACETABULAR CUPS Registered Establishment Name: PLUS ORTHOPEDICS AG. |
|
Classification: PROSTHESIS, KNEE, HINGED (METAL-METAL) Generic Device Name: HINGED KNEE BRACE Proprietary Device Name: PROSTHESIS, KNEE, HINGED (METAL-METAL) Registered Establishment Name: BANYAN HEALTH CARE PRODUCTS, INC.. |
| First Page | Previous Page | Next Page | Last Page |
