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US Food and Drug Administration (FDA) - Orthopedic Devices Registration
FDA Registered Orthopedic Devices - Updated May 2006

What Is Medical Device Listing?

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. 		FDA Devices
FDA Devices
FDA Devices
FDA Devices


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Classification:   PLATE, FIXATION, BONE
Generic Device Name:   MENNEN CLAMP-ON PLATE
Proprietary Device Name:   MENNEN CLAMP-ON PLATE
Registered Establishment Name:  C.H. MEDICAL LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   INSTRUMENTATION OFR MENNEN CLAMP-ON PLATES
Proprietary Device Name:   INSTRUMENTATION OFR MENNEN CLAMP-ON PLATES
Registered Establishment Name:  C.H. MEDICAL LTD..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   FS 1000 KNEE SYSTEM
Registered Establishment Name:  CAMDEN INSTRUMENTS, LLC..
Classification:   BIT, DRILL
Generic Device Name:   BONE DRILL BIT
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  RAY-MED ASSOCIATES, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   TENSIONER
Proprietary Device Name:   AHREND FRACTURE REDUCTION SYSTEM
Registered Establishment Name:  ALLIANCE ORTHOPEDICS, INC..
Classification:   FIXATION ACCESSORY
Generic Device Name:   BONE BAND
Proprietary Device Name:   REDUCTION STRAP
Registered Establishment Name:  ALLIANCE ORTHOPEDICS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   BONE BAND PASSER
Proprietary Device Name:   REDUCTION STRAP PASSER
Registered Establishment Name:  ALLIANCE ORTHOPEDICS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HIATT METAL PRODUCTS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   ESKA MODULAR HIP SYSTEM
Proprietary Device Name:   ESKA MODULAR HIP SYSTEM
Registered Establishment Name:  ESKA IMPLANTS GMBH & CO..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SURGICAL INSTRUMENTS, ORTHOPEDIC
Proprietary Device Name:   ESKA MODULAR HIP SYSTEM INSTRUMENTS
Registered Establishment Name:  ESKA IMPLANTS GMBH & CO..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDER, ORTHOPEDIC, WEBSTER, BAUMGARTNER, MAYO HEGAR, MATHIUE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ATLANTIC ENTERPRISES.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC (MULTIPLE BRANDS)
Registered Establishment Name:  RKZ SURGICAL (PVT) LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   QUICKDRAW BONE HARVESTER
Registered Establishment Name:  PARADIGM BIODEVICES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   RED ROSE ENTERPRISES
Registered Establishment Name:  RED ROSE ENTERPRISES.
Classification:   MONITOR, PRESSURE, INTRACOMPARTMENTAL
Generic Device Name:   COMPARTMENT PRESSURE MONITOR
Proprietary Device Name:   MONITOR, PRESSURE SENSE
Registered Establishment Name:  MILLENNIUM MEDICAL TECHNOLOGIES, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   EXTERNAL WRIST FIXATOR
Proprietary Device Name:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE/COMBINATION, MULTIPLE COMPONENT
Registered Establishment Name:  MILLENNIUM MEDICAL TECHNOLOGIES, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   K-WIRE
Proprietary Device Name:   PCW PERCUTANEOUS COMPRESSION WIRE
Registered Establishment Name:  MILLENNIUM MEDICAL TECHNOLOGIES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  HAIKOU CITY HAIFA FOREIGN TRADING & INDUSTRIAL CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   RMSON SURGICO
Registered Establishment Name:  RMSON SURGICO.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   HOME & PORTABLE TRACTION DEVICE FOR LOWER BACK
Proprietary Device Name:   ISO-TRAC
Registered Establishment Name:  TRACTION SOLUTIONS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   DAR EXPO
Registered Establishment Name:  DAR EXPO.
Classification:   TREPHINE
Generic Device Name:   TREPHINES
Proprietary Device Name:   FRESISSIMA
Registered Establishment Name:  FRESISSIMA IMPLANTA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   PIN COVER
Proprietary Device Name:   PIN COVER
Registered Establishment Name:  ASPEN SURGICAL PRODUCTS, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS TYPES OF BUCKS TRACTIONS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VIRGINIA PATIENT CARE.
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS TYPES OF HEAD HALTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VIRGINIA PATIENT CARE.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTIONS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VIRGINIA PATIENT CARE.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICAL SUPPLY CO..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   ARTSCAN 1000
Registered Establishment Name:  ARTSCAN OY.
Classification:   TESTER, STIFFNESS, CARTILAGE, ARTHROSCOPIC
Generic Device Name:   CARTILAGE STIFFNESS TESTING DEVICE
Proprietary Device Name:   ARTSCAN 200; ARTHROSCOPE CARTILAGE STIFFNESS TESTER
Registered Establishment Name:  ARTSCAN OY.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   CAST CUTTER SAW; PLASTER SAW
Proprietary Device Name:   PLASTER SAW OSCIMED 2000
Registered Establishment Name:  OSCITRONIC S.A..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SUGICAL INSTRUMENT
Proprietary Device Name:   TECH-MED HAND-HELD ARTHROSCOPIC SURGICAL INSTRUMENTS
Registered Establishment Name:  TECH-MED DEVICES, LLC..
Classification:   SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
Generic Device Name:   PROSTHESIS, FINGER JOINT (METACARPOPHALANGEAL)
Proprietary Device Name:   ASCENSION MCP
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   PROSTHESIS,FINGER,SEMI-CONSTRAINED,PROLYTIC CARBON,UNCEMENTED
Generic Device Name:   ASCENSION PIP
Proprietary Device Name:   ASCENSION PIP
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Generic Device Name:   FINGER JOINT POLYMER CONSTRAINED PROSTHESIS
Proprietary Device Name:   ASCENSION SILICONE MCP
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Generic Device Name:   RADIAL HEAD PROSTHESIS
Proprietary Device Name:   ASCENSION MODULAR RADIAL HEAD
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   PROSTHESIS, WRIST, CARPAL TRAPEZIUM
Generic Device Name:   CARPOMETACARPAL PROSTHESIS
Proprietary Device Name:   ASCENSION CMC
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   PROSTHESIS, WRIST, HEMI-, ULNAR
Generic Device Name:   ULNAR HEAD IMPLANT
Proprietary Device Name:   ASCENSION MUH
Registered Establishment Name:  ASCENSION ORTHOPEDICS, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICAL IMPLANTA MEDIZINTECHNIK GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICAL IMPLANTA MEDIZINTECHNIK GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDICAL IMPLANTA MEDIZINTECHNIK GMBH.

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Last Modified: 29 April 2006
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