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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: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE Registered Establishment Name: JR BROTHERS SURGICAL INSTRUMENTS. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: ULC SPINAL PEDICLE SCREW SYSTEM Registered Establishment Name: OTIS BIOTECH CO., LTD. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: SCISSORS, ORTHOPEDIC, SURGICAL#ORTHOPEDIC Registered Establishment Name: TAKS INDUSTRY. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR#ORTHOPEDIC Registered Establishment Name: TAKS INDUSTRY. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE#ORTHOPEDIC Registered Establishment Name: TAKS INDUSTRY. |
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Classification: CALIPER Generic Device Name: CALIPER,CLINICAL USE Proprietary Device Name: CALIPER#ORTHOPEDIC Registered Establishment Name: TAKS INDUSTRY. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS Proprietary Device Name: BONE SHARK AND MULTIPLE MANUAL SURGICAL INSTRUMENTS Registered Establishment Name: MEDICAL INNOVATORS. |
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Classification: DISPENSER, CEMENT Generic Device Name: CEMENT DISPENSER Proprietary Device Name: EZFLOW CEMENT DELIVERY SYSTEM Registered Establishment Name: MEDTECH COSTA RICA S.A.. |
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Classification: PLATE, FIXATION, BONE Generic Device Name: PLATE, FIXATION, BONE Proprietary Device Name: PLATE, FIXATION, BONE ORTHOPEDIC Registered Establishment Name: BONECARE IMPLANTS. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: SCREW, FIXATION, BONE Proprietary Device Name: SCREW, FIXATION, BONE ORTHOPEDIC Registered Establishment Name: BONECARE IMPLANTS. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: NAIL, FIXATION, BONE Proprietary Device Name: NAIL, FIXATION, BONE ORTHOPEDIC Registered Establishment Name: BONECARE IMPLANTS. |
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Classification: COMPONENT, CAST Generic Device Name: ORTHOPEDIC AND SPORT BRACES Proprietary Device Name: MULTIPLE Registered Establishment Name: DONGGUAN PAIHO TEXTILE COMPANY. |
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Classification: COMPONENT, CAST Generic Device Name: ORTHOPEDIC AND SPORT BRACES Proprietary Device Name: MULTIPLE Registered Establishment Name: TAIWAN PAIHO LIMITED. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS, ORTHOPEDIC, SURGICAL Proprietary Device Name: MULTIPLE PRODUCT NAMES Registered Establishment Name: PROWESS INTERNATIONAL. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: HOLDER NEEDLE Proprietary Device Name: NONE Registered Establishment Name: ASH INSTRUMENTS, INC.. |
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Classification: PIN, FIXATION, THREADED Generic Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION Proprietary Device Name: STEALTH THREADED PIN Registered Establishment Name: R&R MEDICAL, INC.. |
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Classification: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Generic Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES Proprietary Device Name: STEALTH EXTERNAL FIXATOR Registered Establishment Name: R&R MEDICAL, INC.. |
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Classification: ACCESSORY, SYSTEM, EXTERNAL FIXATOR, CONTAINING ANTIMICROBIAL AGENT Generic Device Name: EXTERNAL FIXATION Proprietary Device Name: EXTERNAL FIXATION Registered Establishment Name: GEXFIX SA. |
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Classification: SCREW, FIXATION, BONE Generic Device Name: BONE SCREW Proprietary Device Name: ROI FUSION RODS AND PLATES Registered Establishment Name: REILEY ORTHOPEDIC, INC.. |
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Classification: CEMENT, BONE, VERTEBROPLASTY Generic Device Name: PMMA BONE CEMENT Proprietary Device Name: SPINEPLEX RADIOPAQUE BONE CEMENT Registered Establishment Name: STRYKER INTERVENTIONAL PAIN. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: CEMENT MIXERS FOR CLINICAL USE Proprietary Device Name: MIXEVAC CEMENT MIXER AND FUME EVACUATOR, MIXEVAC II HIGH VACUUM KIT,MIXEVAC II H Registered Establishment Name: STRYKER INTERVENTIONAL PAIN. |
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Classification: ARTHROSCOPE Generic Device Name: VARIOUS ARTHROSCOPIC INSTRUMENTS Proprietary Device Name: MULTIPLE ARTHROSCOPIC INSTRUMENTS Registered Establishment Name: STRYKER INTERVENTIONAL PAIN. |
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Classification: STAPLE, FIXATION, BONE Generic Device Name: STAPLE SYSTEM Proprietary Device Name: WARMSYSTEM WITH STIMULINKS Registered Establishment Name: INTELIFUSE, INC.. |
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Classification: BENDER Generic Device Name: ROD BENDER Proprietary Device Name: ISSYS ROD BENDER Registered Establishment Name: HONNIC DEVELOPMENT LTD.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Generic Device Name: ANTERIOR CERVICAL SCREW SPINAL FIXATION SYSTEM Proprietary Device Name: ABC Registered Establishment Name: AESCULAP, INC.. |
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Classification: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Generic Device Name: TOTAL KNEE SYSTEM Proprietary Device Name: COLUMBUS Registered Establishment Name: AESCULAP, INC.. |
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Classification: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Generic Device Name: TOTAL HIP SYSTEM Proprietary Device Name: EXCIA Registered Establishment Name: AESCULAP, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: MANUAL ORTHOPEDIC INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: AESCULAP, INC.. |
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Classification: APPLIANCE, FIXATION, SPINAL INTERLAMINAL Generic Device Name: SPINAL SYSTEM Proprietary Device Name: S4 Registered Establishment Name: AESCULAP, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: SPINAL SYSTEM Proprietary Device Name: S4 Registered Establishment Name: AESCULAP, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: SPINAL SYSTEM Proprietary Device Name: S4 Registered Establishment Name: AESCULAP, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS,ORTHOPEDIC Proprietary Device Name: NONE Registered Establishment Name: T.A. WALTHEM & COMPANY. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: NONE Registered Establishment Name: T.A. WALTHEM & COMPANY. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: NONE Registered Establishment Name: T.A. WALTHEM & COMPANY. |
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Classification: CALIPER Generic Device Name: CALIPER,CLINICAL USE Proprietary Device Name: NONE Registered Establishment Name: T.A. WALTHEM & COMPANY. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: RONGEUR ORTHOPEDIC Registered Establishment Name: WORLD INSTRUMENTS. |
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Classification: PROBE Generic Device Name: PROBE Proprietary Device Name: PROBE ORTHOPEDIC Registered Establishment Name: WORLD INSTRUMENTS. |
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Classification: RONGEUR Generic Device Name: RONGEURS Proprietary Device Name: RONGEUR Registered Establishment Name: SKET IND.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: HITTER IMPEX Registered Establishment Name: HITTER IMPEX. |
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Classification: PROBE Generic Device Name: PROBES Proprietary Device Name: HITTER IMPEX Registered Establishment Name: HITTER IMPEX. |
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