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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 (IRELAND) 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 (IRELAND) LTD..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) 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 (IRELAND) 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 (IRELAND) LTD..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) 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 (IRELAND) 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 (IRELAND) LTD..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) 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 (IRELAND) 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 (IRELAND) 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 (IRELAND) 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 (IRELAND) 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 (IRELAND) 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 (IRELAND) LTD..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   SUTURE APPLICATOR
Proprietary Device Name:   AXYA MEDICAL, INC. BONE ANCHOR SYSTEM & KIT
Registered Establishment Name:  AXYA MEDICAL, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE ACHOR
Proprietary Device Name:   AXYA MEDICAL INC AXYLOOP BONE ANCHOR
Registered Establishment Name:  AXYA MEDICAL, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   BIO-ABSORBABLE BONE ANCHOR
Proprietary Device Name:   AXYA MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
Registered Establishment Name:  AXYA MEDICAL, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   FASTENER
Proprietary Device Name:   KARL STORZ FASTENER
Registered Establishment Name:  MTP MEDICAL TECHNICAL PROMOTION GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION FASTENERS
Proprietary Device Name:   NON-STERILE KIRSCHNER WIRES & STEINMANN PINS
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   PROXIMAL FEMORAL IMPLANT
Proprietary Device Name:   SYNTECH-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   BONE FIXATION PIN
Proprietary Device Name:   SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   SMALL EXTERNAL FIXATION SYSTEM
Proprietary Device Name:   SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTEC SCIENTIFIC CORP..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   QUICK CONNECT DRILL BIT
Registered Establishment Name:  MEDCON LLC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   PIN PULLER
Proprietary Device Name:   PIN PULLER
Registered Establishment Name:  MEDCON LLC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR SPINAL FIXATION PLATE
Proprietary Device Name:   BODYFORM THORACO-THUMBAR FIXATION SYSTEM
Registered Establishment Name:  THEKEN SPINE LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS HIP RETRACTORS
Proprietary Device Name:   HIP RETRACTORS
Registered Establishment Name:  MEDICAL DEVICE CONCEPTS, LLC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
Proprietary Device Name:   MACROPORE OS SPINAL,HYDROSORB SPINE SYSTEM
Registered Establishment Name:  MACROPORE BIOSURGERY, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   CEMENT RESTRICTOR
Proprietary Device Name:   MACROPORE IB RESORBABLE PLUG
Registered Establishment Name:  MACROPORE BIOSURGERY, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE SCREWS AND TACKS
Proprietary Device Name:   MACROPORE OS
Registered Establishment Name:  MACROPORE BIOSURGERY, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MANUALLY OPERATED ORTHOPEDIC INSTRUMENT AND ATTACHMENTS
Proprietary Device Name:   AUTOIMPACTOR DEVICE
Registered Establishment Name:  FINSBURY INSTRUMENTS, LTD..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   TEMPLATE
Registered Establishment Name:  WILLIAMS INDUSTRIES, INC..
Classification:   TAMP
Generic Device Name:   TAMP
Proprietary Device Name:   KINE-BOHNE-TAMP
Registered Establishment Name:  PFAU MEDIZINISCHE INSTRUMENTE GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   DRILLS
Proprietary Device Name:   DRILLS
Registered Establishment Name:  PRECIMED, INC..
Classification:   REAMER
Generic Device Name:   REAMERS
Proprietary Device Name:   REAMERS
Registered Establishment Name:  PRECIMED, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   PANORAMA INTL.
Proprietary Device Name:   PANORAMA INTL.
Registered Establishment Name:  PANORAMA INTL..

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Last Modified: 29 April 2006
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