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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:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   DENTAL, SURGICAL, ORTHOPEDIC, NEEDLE HOLDER
Proprietary Device Name:   NEEDLE-HOLDER, CASTROVIEJO
Registered Establishment Name:  B.T.I. BIOTECHNOLOGY INSTITUTE, S.L..
Classification:   SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
Generic Device Name:   EXTERNAL FIXATOR ACCESSORY FOR RECONSTRUCTION OF LONG BONES.
Proprietary Device Name:   RING FIXATORS/HALF-RING
Registered Establishment Name:  CYBERORTHOLOGY, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   METALLIC COMPONENT FOR EXTERNAL FIXATION SYSTEM
Proprietary Device Name:   CYBERORTHOLOGY CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RI
Registered Establishment Name:  CYBERORTHOLOGY, INC..
Classification:   REAMER
Generic Device Name:   ACETABULAR REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  ENDO PLANT MUELLER GMBH.
Classification:   EXTRACTOR
Generic Device Name:   HIP STEM EXTRACTOR
Proprietary Device Name:   ENDODRIVER
Registered Establishment Name:  ENDO PLANT MUELLER GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDOS.
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   STERNAL KNIFE
Proprietary Device Name:   LEBSCHE STERNAL KNIFE
Registered Establishment Name:  MEDOS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS SCISSORS FOR ORTHOPEDIC USE
Proprietary Device Name:   NONE
Registered Establishment Name:  MEDOS.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHRONET STAINLESS STEEL BLADES, VARIOUS
Proprietary Device Name:   ARTHRONET STAINLESS STEEL BLADES, VARIOUS
Registered Establishment Name:  ARTHRONET GMBH & CO. KG.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   ORTHOPEDIC MANUAL INSTRUMENTS, VARIOUS
Proprietary Device Name:   ARTHRONET MILLENIUM I& II HAND INSTRUMENTS
Registered Establishment Name:  ARTHRONET GMBH & CO. KG.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   EXTERNAL FIXATION SYSTEM
Proprietary Device Name:   FEP
Registered Establishment Name:  MERIDAN MEDICAL.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVERDOOR TRACTION SET
Proprietary Device Name:   OVERDOOR TRACTION SET
Registered Establishment Name:  DYNATRONICS CORP. CHATTANOOGA OPERATIONS.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  FLAVIO MEDICOS.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   FLAVIO MEDICOS
Registered Establishment Name:  FLAVIO MEDICOS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   FLAVIO MEDICOS
Registered Establishment Name:  FLAVIO MEDICOS.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  FLAVIO MEDICOS.
Classification:   GENERATOR,SHOCK-WAVE,(FOR PAIN RELIEF)
Generic Device Name:   EXTRACORPOREAL SHOCKWAVE THERAPY SYSTEM
Proprietary Device Name:   SONOCUR
Registered Establishment Name:  SIEMENS AG, MEDICAL SOLUTIONS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL
Registered Establishment Name:  STEEL TOP ENT..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPE OF PNEUMATIC POWERED ORTHOPAE. SURGICAL INSTRMNTS & ACCESSORIES,ATT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   VARIOUS TYPES OF NON-POROUS CALCIUM-PHOS METAL,POLY,UNCEMENT,SEMI-CONST,HIP PROS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED,NON-PROUS UNCEMENTED METAL,CERAM,POLY SEMI-CONST HIP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S.-SAINT PRIEST.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINE PEDICLE SCREW SYSTEM
Proprietary Device Name:   UNIMAX
Registered Establishment Name:  PISHARODI SURGICALS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   CERVICAL PLATE
Proprietary Device Name:   RADIX CERVICAL PLATE
Registered Establishment Name:  PISHARODI SURGICALS, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   LEFORTE SYSTEM PLATES
Registered Establishment Name:  JEIL MEDICAL CORPORATION.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   LEFORTE SYSTEM SCREWS
Registered Establishment Name:  JEIL MEDICAL CORPORATION.
Classification:   BIT, DRILL
Generic Device Name:   SURGICAL DRILL BIT
Proprietary Device Name:   MULTIPLE: 112-M SERIES SURGICAL DRILL BIT
Registered Establishment Name:  JEIL MEDICAL CORPORATION.
Classification:   SCREWDRIVER
Generic Device Name:   MANUAL SCREW DRIVER
Proprietary Device Name:   MULTIPLE: 113 M SERIES
Registered Establishment Name:  JEIL MEDICAL CORPORATION.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES UMKIRCH.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS TYPES AND SIZES OF SOFT TISSUE FASTNERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES AND SIZES OF PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES MEZZOVICO.

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Last Modified: 29 April 2006
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