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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:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES OF WIRE TAMPES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   WIRE PASSER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   PARHAM-MARTIN BAND CLAMP
Proprietary Device Name:   PARHAM-MARTIN BAND CLAMP
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES OF PROSTHESIS PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   BENDER
Generic Device Name:   VARIOUS TYPES OF BENDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF WIRE AND PIN CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLTS, NUTS AND WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   FILE
Generic Device Name:   VARIOUS TYPES OF SURGICAL FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   BROACH
Generic Device Name:   VARIOUS TYPES OF BROACHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF KNIFES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS TYPES OF IMPLANT STARTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF BONE AWLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   TREPHINE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC TREPHINES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS TYPES OF COMPRESSION INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   SKID, BONE
Generic Device Name:   VARIOUS TYPES OF BONE SKIDS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   VARIOUS TYPES OF PUNCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PASSER
Generic Device Name:   SAW PASSER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS TYPES OF DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   TEMPLATE
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   CARPAL LUNATE SIZING SET
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   CMW BONE CEMENT
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, FINGER, POLYMER
Generic Device Name:   FINGER IMPLANTS
Proprietary Device Name:   SWANSON FINGER JOINT IMPLANT
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, WRIST, CARPAL TRAPEZIUM
Generic Device Name:   WRIST IMPLANTS
Proprietary Device Name:   SWANSON TRAPEZIUM IMPLANT
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, WRIST, SEMI-CONSTRAINED
Generic Device Name:   WRIST IMPLANT
Proprietary Device Name:   SWANSON WRIST IMPLANT
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, TOE, HEMI-, PHALANGEAL
Generic Device Name:   TOE IMPLANT
Proprietary Device Name:   SWANSON GREAT TOE IMPLANT
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
Generic Device Name:   TOE IMPLANTS
Proprietary Device Name:   SWANSON FLEXIBLE HINGE TOE WITH GROMMETS
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, CONSTRAINED, CEMENTED, POLYMER/METAL/METAL
Generic Device Name:   KNEE IMPLANTS
Proprietary Device Name:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, CONSTRAINED, CEMENTED, POLYMER/METAL/MET
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   KNEE IMPLANT
Proprietary Device Name:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   WRIGHT FEMORAL HEAD
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   INFINITY EVOLUTION
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   INFINITY MCCUTCHEN
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   NEXUS
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   CERAMIC FEMORAL HEAD
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   HIP IMPLANT
Proprietary Device Name:   NEXUS MCCUTCHEN
Registered Establishment Name:  WRIGHT MEDICAL TECHNOLOGY, INC..

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Last Modified: 29 April 2006
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