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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:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Generic Device Name:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL (VARIOUS TYPES)
Proprietary Device Name:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL (MULTIPLE BRANDS)
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS TYPES OF ELBOW PROSTHESES, CONSTRAINED, CEMENTED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Generic Device Name:   VARIOUS TYPES OF ELBOW PROSTHESES, HEMI-RADIAL, POLYMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, SHOULDER, NON-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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   VARIOUS TYPES OF METAL HEMI-FEMORAL HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS TYPES OF CEMENT MIXERS FOR CLINICAL USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   VARIOUS TYPES OF CEMENT MONOMER VAPOR EVACUATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES OF CEMENT OBTURATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   VARIOUS TYPES OF ANTIBIOTIC BONE CEMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF SEMI-CONSTRAINED,METAL CERAMIC,CERAMIC METAL,CEMENTED OR UNCEME
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF METAL,POLYMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   SPACER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT SPACERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
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 ORTHOPAEDICS, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES OF INTRAMEDULLARY FIXATION RODS & ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   DISPENSER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT DISPENSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF SINGLE COMPONENT NAIL,BLADE,PLATE COMBO FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ORTHOPAEDICS, INC..

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Last Modified: 29 April 2006
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