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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:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   SPINAL FIXATOR
Proprietary Device Name:   REZAIAN SPINAL FIXATOR
Registered Establishment Name:  SPINAL & ORTHOPEDIC DEVICES, INC..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   INTERLAMINAR CLAMPS
Proprietary Device Name:   INTERLAMINAR CLAMPS
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL SPINE PLATE
Proprietary Device Name:   CODMAN ANTERIOR CERVICAL PLATE SYSTEM
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED,SEMI-CONSTRAINED,ELBOW PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SOCKET PUSHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED,UNCEMENTED METAL,POLY,FEMORAL HEMI-HIP PROS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF METAL,POLY,CEMENTED,UNCEMENTED,CONTRAINED HIP PROSTH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF SEMI-CONSTRAINED HIP PROSTHESES(METAL CEMENT ACET COMPON)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF POLY,METAL,CEMENTED,SEMI-CONST'D,PATELLOFEM-TIB,KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF CEMENTED METAL,POLYMER,SEMI-CONSTRAINED,FEMOROTIBIAL KNEE PROST
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF CEMENTED,METAL,POLYMER,NON-CONSTRAINED,FEMOROTIBIAL,KNEE PROSTH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
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-RAYNHAM.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF METAL UNCEMENTED ACETABULAR COMP. SEMI-CONSTRAINED HIP PROSTHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF METAL,POLYMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF NAIL,BLADE,PLATE MULTI COMPONENT COMBO FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED METAL,POLYMER,SEMI-CONSTRAINED HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   VARIOUS TYPES OF CEMENTED METAL FEMORAL COMPONENT HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   SPACER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT SPACERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF UNCEMENTED METAL,POLYMER,SEMI-CONSTRAINED HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
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-RAYNHAM.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING
Generic Device Name:   VARIOUS TYPES OF MOBILE BEARING,METAL,POLY,SEMI-CONST,PATELLOFEMOROTIB,KNEE PROS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-RAYNHAM.
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-RAYNHAM.
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-RAYNHAM.
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-RAYNHAM.
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-RAYNHAM.
Classification:   TAMP
Generic Device Name:   TAMP
Proprietary Device Name:   TAMP
Registered Establishment Name:  LIFE INSTRUMENT CORP..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  LIFE INSTRUMENT CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   POC ARTHROSCOPE
Registered Establishment Name:  PRECISION OPTICS CORP..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE FIXATION PLATE
Proprietary Device Name:   SCS DISTAL RADIUS FIXATION SYSTEM
Registered Establishment Name:  RMS CO..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CARPAL RELEASE SYSTEM FOR RELEASE OF TRANSVERSE CARPAL LIGAMENT
Proprietary Device Name:   GRS CARPAL TUNNEL RELEASE SYSTEM
Registered Establishment Name:  RMS CO..

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Last Modified: 29 April 2006
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