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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: SCREWDRIVER Generic Device Name: SCREWDRIVER Proprietary Device Name: SCREWDRIVER Registered Establishment Name: TRINITY MEDICAL IMPLANTS, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Proprietary Device Name: MANUAL INSTRUMENT Registered Establishment Name: TRINITY MEDICAL IMPLANTS, INC.. |
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Classification: ACCESSORY, SYSTEM, EXTERNAL FIXATOR, CONTAINING ANTIMICROBIAL AGENT Generic Device Name: DISTAL RADIUS EXTERNAL FIXATOR Proprietary Device Name: FRAGMENT SPECIFIC FIXATOR Registered Establishment Name: DAVID J. SLUTSKY MD. |
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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: REAMER Generic Device Name: VARIOUS TYPES AND SIZES OF REAMERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: AWL Generic Device Name: VARIOUS TYPES AND SIZES OF AWLS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: PASSER Generic Device Name: VARIOUS TYPES AND SIZES OF PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE PASSERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE TWISTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: BENDER Generic Device Name: VARIOUS TYPES AND SIZES OF BENDERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: CUTTER, WIRE Generic Device Name: VARIOUS TYPES AND SIZES OF WIRE CUTTERS Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES AND SIZES OF MISC. ORTHOPEDIC SURGICAL INSTRUMENTS, MANUAL Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: INSTRUMENT, BENDING OR CONTOURING Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: SYNTHES OSTERREICH GMBH. |
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Classification: APPARATUS, TRACTION, NON-POWERED Generic Device Name: VARIOUS TYPES OF INVERSION EQUIPMENT Proprietary Device Name: MULTIPLE Registered Establishment Name: BETO ENG. & MKTG., CO., LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: AFAN SURGICO Registered Establishment Name: AFAN SURGICO. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: LABORATORY SCISSOR Proprietary Device Name: TRAY, TRIMMING, SCISSOR Registered Establishment Name: SACRED INTERNATIONAL. |
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Classification: GONIOMETER, NONPOWERED Generic Device Name: POSTURE INCLINOMETER Proprietary Device Name: CHEK INCLINOMETER Registered Establishment Name: HIGHEST QUALITY HEALTH & FITNESS PRODUCTS LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: GRAYROCKS ENTERPRISES Registered Establishment Name: GRAYROCKS ENTERPRISES. |
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Classification: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Generic Device Name: VERTEBRAL BODY REPLACEMENT Proprietary Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE#ORTHOPEDIC Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOSIS, SPINAL PEDICLE FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: SHIRAZ JAVA SPINAL FIXATION SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF ORTHOPEDIC MANUAL INSTRUMENTS Proprietary Device Name: MULTIPLE Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION Generic Device Name: PEDICLE SCREW SPINAL SYSTEM Proprietary Device Name: SHIRAZ JAVA SPINAL FIXATION SYSTEM Registered Establishment Name: ABBOTT SPINE, INC.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: MULTIPLE Proprietary Device Name: VARIOUS Registered Establishment Name: P.T. GEOMED INDONESIA. |
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Classification: COMPONENT, CAST Generic Device Name: UNDERCAST PADDING Proprietary Device Name: UNDERCAST PADDING Registered Establishment Name: MEDTECS (TAIWAN) CORP.. |
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Classification: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Generic Device Name: VARIOUS TYPES OF SURGICAL INSTRUMENTS AND STERILE WASHER AND SCREW ACCESSORY Proprietary Device Name: NILNAV TOOLSET AND NILNAV WASHER AND SCREW Registered Establishment Name: NILNAV PTY. LTD.. |
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Classification: BIT, DRILL Generic Device Name: VARIOUS TYPES OF FINGER NAIL DRILL Proprietary Device Name: FINGER NAIL DRILL Registered Establishment Name: TECHNIMEN SKILLERS. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: VARIOUS TYPE OF NEEDLE HOLDER, GILLIES, MAYO, MATHIEU, WEBSTER Proprietary Device Name: VARIOUS TYPE OF NEEDLE HOLDER, GILLIES, MAYO, MATHIEU, WEBSTER Registered Establishment Name: TECHNIMEN SKILLERS. |
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Classification: NAIL, FIXATION, BONE Generic Device Name: BONE TRIMMER Proprietary Device Name: NAIL TRIMMER, NAIL DRILL Registered Establishment Name: TECHNIMEN SKILLERS. |
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Classification: RONGEUR Generic Device Name: BONE-RONGEUR FORCEPS-HOHLMEISSELZANGEN/SHEARER, CICHERELLI, HAKANSSON, BLUMENTHA Proprietary Device Name: BONE-RONGEUR FORCEPS-HOHLMEISSELZANGEN/SHEARER, CICHERELLI, HAKANSSON, BLUMENTHA Registered Establishment Name: TECHNIMEN SKILLERS. |
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Classification: TWISTER, WIRE Generic Device Name: VARIOUS TYPES OF WIRE HOLDING CLAMPS Proprietary Device Name: WIRE HOLDING CLAMP, VARIOUS SIZES Registered Establishment Name: TECHNIMEN SKILLERS. |
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Classification: INSTRUMENT, CAST REMOVAL, AC-POWERED Generic Device Name: EQ-10 CAST REMOVAL Proprietary Device Name: CAST CUTTER SAW MOD. EQ-10CH Registered Establishment Name: EQUIMEDICA SRL. |
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Classification: ACCESSORIES,ARTHROSCOPIC Generic Device Name: VARIOUS MANUAL ARTHOSCOPIC ACCESSORIES Proprietary Device Name: ARTHROSCOPIC ACCESSORIES Registered Establishment Name: MTM MEDIZINTECHNIK GMBH. |
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Classification: MIXER, CEMENT, FOR CLINICAL USE Generic Device Name: VARIOUS TYPES OF STAINLESS STEEL BOWLS Proprietary Device Name: STAINLESS STEEL BOWLS Registered Establishment Name: METALURGICA FAVA IND. E COM. LTDA. |
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Classification: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Generic Device Name: SAME Proprietary Device Name: MULTIPLE Registered Establishment Name: MAR-LEE COMPANIES. |
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Classification: HOLDER, NEEDLE; ORTHOPEDIC Generic Device Name: MULTIPLE Proprietary Device Name: MULTIPLE Registered Establishment Name: M/S. G.A. SURGICAL (PVT) LTD.. |
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Classification: SCISSORS, ORTHOPEDIC, SURGICAL Generic Device Name: SCISSORS Proprietary Device Name: THE FAMOUS SURGICRAFTS Registered Establishment Name: THE FAMOUS SURGICRAFTS. |
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Classification: RONGEUR Generic Device Name: RONGEUR Proprietary Device Name: THE FAMOUS SURGICRAFTS Registered Establishment Name: THE FAMOUS SURGICRAFTS. |
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Classification: TEMPLATE Generic Device Name: TEMPLATE Proprietary Device Name: TEMPLATE Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: PASSER, WIRE, ORTHOPEDIC Generic Device Name: VARIOUS TYPES OF GUIDE WIRES Proprietary Device Name: GUIDE WIRE Registered Establishment Name: SPINE WAVE, INC.. |
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Classification: TAMP Generic Device Name: VARIOUS TYPES OF TAMPS Proprietary Device Name: TAMP Registered Establishment Name: SPINE WAVE, INC.. |
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