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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, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE Generic Device Name: CEMENTLESS HIP STEM Proprietary Device Name: LINEAR POROUS COATED HIP STEM, FOUNDATION POROUS COATED HIP STEM, REVELATION POR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER Generic Device Name: KNEE SYSTEM Proprietary Device Name: 3DKNEE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Generic Device Name: CONSTRAINED LINER Proprietary Device Name: CONSTRAINED LINER Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE Generic Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES Proprietary Device Name: TRUE/LOK MONOLATERAL/BILATERAL FIXATOR Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Proprietary Device Name: CYCLONE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Generic Device Name: PRESS-FIT HUMERAL STEM Proprietary Device Name: FOUNDATION HEMI SHOULDER Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: ENCORE SCREWDRIVER Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Proprietary Device Name: SELBY (VARIFIX) Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Generic Device Name: PROSTHESIS, HIP Proprietary Device Name: Z-SERIES MODULAR HIP Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: SELBY (VARIFIX) Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: REAMER Generic Device Name: VARIOUS TYPES OF REAMERS Proprietary Device Name: ENCORE REAMERS Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: BROACH Generic Device Name: VARIOUS TYPES OF BROACHES Proprietary Device Name: ENCORE BROACHES Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF RONGEURS Proprietary Device Name: ENCORE RONGEURS Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: IMPACTOR Generic Device Name: VARIOUS TYPES OF IMPACTORS Proprietary Device Name: ENCORE IMPACTORS Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: ENCORE TEMPLATE Registered Establishment Name: ENCORE MEDICAL, L.P.. |
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Classification: RONGEUR Generic Device Name: VARIOUS TYPES OF RONGEURS Proprietary Device Name: MULTIPLE Registered Establishment Name: ROBERT MUELLER INSTRUMENTE. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: NO COMMON NAME LISTED Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: FAUSTINO RINCON. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: DOUBLE ENDED FORAMINAL PROBE; POSTERIOR DISC EVACUATOR Proprietary Device Name: AMSEN Registered Establishment Name: ADVANCED SPINE TECHNOLOGY, INC.. |
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Classification: IMPLANT, FIXATION DEVICE, SPINAL Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: ADVANCED SPINE TECHNOLOGY, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: TRIFIX SYSTEM Proprietary Device Name: TRI-FIX SPINAL FIXATION SYSTEM Registered Establishment Name: ADVANCED SPINE TECHNOLOGY, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: TRIPLEFIX SYSTEM Proprietary Device Name: TRIFIX SPINAL FIXATION SYSTEM Registered Establishment Name: ADVANCED SPINE TECHNOLOGY, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: WINDOW CERVICAL DYNAMIC PLATE SYSTEM Proprietary Device Name: WINDOW CERVICAL DYNAMIC PLATE SYSTEM Registered Establishment Name: ADVANCED SPINE TECHNOLOGY, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: FIXATION PIN Proprietary Device Name: STEINMANN PIN Registered Establishment Name: SIMPEX MEDICAL, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: FIXATION PIN Proprietary Device Name: THREADED STEINMANN PIN Registered Establishment Name: SIMPEX MEDICAL, INC.. |
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Classification: BIT, DRILL Generic Device Name: DRILL, SURGICAL, ORTHOPEDIC Proprietary Device Name: NO PROPRIETARY NAME LISTED Registered Establishment Name: PETER BUMUELLER. |
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Classification: CALIPER Generic Device Name: VARIOUS TYPES OF CALIPERS Proprietary Device Name: MULTIPLE PRIVATE LABEL Registered Establishment Name: PETER BUMUELLER. |
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Classification: BRACE, DRILL Generic Device Name: VARIOUS TYPES OF DRILLS Proprietary Device Name: MULTIPLE PRIVATE LABEL Registered Establishment Name: PETER BUMUELLER. |
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Classification: CALIPER Generic Device Name: CALIPER Registered Establishment Name: SASCO, INC.. |
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Classification: DYNAMOMETER, AC-POWERED Generic Device Name: SPINAL STIFFNESS GAUGE Proprietary Device Name: SPINAL STIFFNESS GAUGE Registered Establishment Name: MEKANIKA, INC.. |
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Classification: BIT, DRILL Generic Device Name: BONE DRILL BIT Proprietary Device Name: SAFEPATH Registered Establishment Name: MEKANIKA, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: RICHBOLT ENTERPRISES Registered Establishment Name: RICHBOLT ENTERPRISES. |
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Classification: CUTTER, WIRE Generic Device Name: WIRE CUTTER Proprietary Device Name: RICHBOLT ENTERPRISES Registered Establishment Name: RICHBOLT ENTERPRISES. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: COMPONENT FOR EXTERNAL FIXATION DEVICE Proprietary Device Name: AUTOGENESIS(TM) AUTOMATOR(TM) Registered Establishment Name: AUTOGENESIS, INC.. |
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Classification: COMPONENT, TRACTION, INVASIVE Generic Device Name: AUTOMATIC DISTRACTION COMPONENT FOR EXTERNAL FIXATION DEVICES Proprietary Device Name: AUTOGENESIS AUTOMATOR 2000 Registered Establishment Name: AUTOGENESIS, INC.. |
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Classification: PIN, FIXATION, SMOOTH Generic Device Name: AUTOMATIC DISTRACTION COMPONENT FOR EXTERNAL FIXATION DEVICES Proprietary Device Name: CF AUTOMATOR Registered Establishment Name: AUTOGENESIS, INC.. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS Proprietary Device Name: MULTIPLE Registered Establishment Name: SCICAN. |
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Classification: BELT, PELVIC, TRACTION Generic Device Name: PELVIC TRACTION BELT Registered Establishment Name: KENAD SG MEDICAL, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: ORTHOPEDIC SCISSORS Registered Establishment Name: KENAD SG MEDICAL, INC.. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: FIXATION DEVICES (BONE SCREWS AND OTHER COMPONENTS) Registered Establishment Name: SUPREME SCREW PRODUCTS, INC.. |
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Classification: PROBE Generic Device Name: COAGULATION PROBE Proprietary Device Name: COAGULATION PROBE Registered Establishment Name: UNITED STATES ENDOSCOPY GROUP, INC.. |
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