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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:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   MULTIPLE BRANDS
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
Classification:   DISPENSER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT DISPENSERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   VARIOUS TYPES OF CEMENT MONOMER VAPOR EVACUATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES OF CEMENT OBTURATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   VARIOUS TYPES OF ANTIBIOTIC BONE CEMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
Classification:   SPACER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT SPACERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY INTL., LTD..
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 INTL., LTD..
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 INTL., LTD..
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  S.U.A. MARTIN GMBH&CO.KG.
Classification:   PROSTHESIS, UPPER FEMORAL
Generic Device Name:   VARIOUS SIZES OF UPPER FEMORAL PROSTHESIS
Proprietary Device Name:   VARIOUS SIZES OF UPPER FEMORAL PROSTHESIS
Registered Establishment Name:  WILH.JUL.TEUFEL GMBH & CO. KG.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   POLYGONIOMETER
Proprietary Device Name:   POLYGONIOMETER
Registered Establishment Name:  WILH.JUL.TEUFEL GMBH & CO. KG.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   COLLINS DYNAMOMETER IN DIFFERENT SIZES
Proprietary Device Name:   COLLINS DYNAMOMETER
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC EXTRACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.
Classification:   APPLIER, CERCLAGE
Generic Device Name:   PARHAM-MARTIN BONE CLAMP
Proprietary Device Name:   PARHAM-MARTIN BONE CLAMP
Registered Establishment Name:  WITTE GMBH CHIRURGISCHE INSTRUMENTE.

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Last Modified: 29 April 2006
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