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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:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPES OF METAL COMPOSITE MULTICOMP,NAIL,BLADE,BLADE FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, HARD TISSUE
Generic Device Name:   VARIOUS TYPES OF BIODEGRADABLE HARD TISSUE FIXATION FASTENER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF POROUS UNCEMENTED,METAL,POLY,SEMI-CONST,HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS TYPES OF NONDEGRADABLE SOFT TISSUE FIXATION FASTENERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   CALIPER
Generic Device Name:   SPECIAL DISTANCE MEASURE
Registered Establishment Name:  ANTHONY PRODUCTS, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS PELVIC TRACTION BELTS
Registered Establishment Name:  ANTHONY PRODUCTS, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   TENDON STRIPPER
Proprietary Device Name:   BUNNELL TENDON STRIPPER
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES OF INTRAMEDULLARY RODS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   AEROPLANE SPLINT
Proprietary Device Name:   AEROPLANE SPLINT
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES OF WEIGHTS, CORD, FRAMES, AND OTHER TRACTION ACC.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS CARTILAGE KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS STYLES OF STEINMANN PINS AND KIRSHNER WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SKID, BONE
Generic Device Name:   BONE SKID
Proprietary Device Name:   MURPHY LANE BONE SKID
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   FEMORAL NECK PUNCH
Proprietary Device Name:   FEMORAL NECK PUNCH
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS TYPES OF PROSTHESIS DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   TAP, BONE
Generic Device Name:   BONE TAP
Proprietary Device Name:   BONE TAP
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   BRACE, DRILL
Generic Device Name:   DRILL BRACE
Proprietary Device Name:   DRILL BRACE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PROSTHESIS, UPPER FEMORAL
Generic Device Name:   THOMPSON AND MOORE TYPE HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE CUP
Proprietary Device Name:   ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE CUP
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS STYLES OF THREADED STEINMANN PINS AND KIRSHNER WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   VARIOUS INPLANT FIXATION DEVICES, SPINAL - STERILE AND NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL IMPLANT FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR IMPLANT FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ACCESSORIES, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL IMPLANT FIXATION DEVICE
Proprietary Device Name:   TSRH CROSSLINK SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL IMPLANT FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY
Generic Device Name:   CERVICAL IMPLANT FIXATION DEVICE
Proprietary Device Name:   ORION ANTERIOR CERVICAL PLATE SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   CABLE DEVICES-STERILE AND NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREWS-STERILE AND NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPIC SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS SURGICAL BURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   CRIMPER, PIN
Generic Device Name:   VARIOUS TENSION CRIMPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   REAMER
Generic Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Proprietary Device Name:   MULTIPLE (ORTHOPEDIC REAMERS)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TWIST, BIT DRILLS
Proprietary Device Name:   MULTIPLE TWIST, BIT DRILLS
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   AXIS, TIMESH, ATLAS
Proprietary Device Name:   AXIS, TIMESH, ATLAS
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SCREW, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   UCSS, ATLAS
Proprietary Device Name:   UCSS, ATLAS
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   WIRE, SURGICAL
Generic Device Name:   SURGICAL CABLE
Proprietary Device Name:   ATLAS
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..

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Last Modified: 29 April 2006
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