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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, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   ACETABULAR COMPONENT
Proprietary Device Name:   OSTEONICS CONCENTRIC POLYETHYLENE ACETABULAR CUP
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   ARTIFICIAL HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   ARTIFICIAL HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   ARTIFICIAL HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   BONE CEMENT
Generic Device Name:   BONE CEMENT
Proprietary Device Name:   SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   VARIOUS HIP IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   METAL/CERAMIC HIP PROSTHESIS
Proprietary Device Name:   TRIDENT SYSTEM
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   ARTIFICIAL HIP IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   ARTIFICIAL HIP IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   CEMENT OBTURATOR
Generic Device Name:   OBTURATOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   PRESS-FIT,UNCEMENTED KNEE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   HUMERAL STEMS/HEADS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS CABLE SYSTEM COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER IRELAND, LTD. OSTEONICS.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   MEDIFIX ARTHROSCOPE
Registered Establishment Name:  MEDIFIX, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   CERAMIC FEMORAL HEAD
Proprietary Device Name:   APEX MODULAR TM ALUMINA FEMORAL HEAD
Registered Establishment Name:  OMNI LIFE SCIENCE, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   ACETABULAR CUP, UNCEMENTED
Proprietary Device Name:   APEX MODULAR ACETABULAR CUP
Registered Establishment Name:  OMNI LIFE SCIENCE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   APEX MODULAR INSTRUMENT SYSTEM
Registered Establishment Name:  OMNI LIFE SCIENCE, INC..
Classification:   IMPACTOR
Generic Device Name:   INSERTER
Proprietary Device Name:   INSERTER
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC INSTRUMENT HANDLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   ORTHOPEDIC WIRE, PASSER
Proprietary Device Name:   K-WIRE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS GUIDES AND TEMPLATES FOR ORTHOPEDIC USE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC BONE TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF WRENCHES FOR ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ALPHATEC SPINE, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATES, VARIOUS SIZES
Proprietary Device Name:   PLATE, FIXATION, BONE
Registered Establishment Name:  BHH MIKROMED.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   CORTICAL, CANNULATED HEXCAP & CANCELLOUS SCREWS
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  BHH MIKROMED.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   GUIDE ROD
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  BHH MIKROMED.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS THREADED PINS
Proprietary Device Name:   PIN, FIXATION, THREADED#ORTHOPEDIC
Registered Establishment Name:  BHH MIKROMED.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   MODULAR FEMORAL HIP REPLACEMENT SYSTEM
Proprietary Device Name:   THE MARGON HIP REPLACEMENT SYSTEM
Registered Establishment Name:  PORTLAND ORTHOPAEDICS PTY. LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM
Proprietary Device Name:   OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM
Registered Establishment Name:  OSTEOMEDICS, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC SUPPORT AND TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MGRM MEDICARE LTD..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS TYPES OF TRACTION SPLINTS FOR EXTREMITIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MGRM MEDICARE LTD..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   BONE FIXATION SYSTEM
Proprietary Device Name:   ACCESSORIES TO THE ORTHOFIX MODULSYSTEM
Registered Establishment Name:  INTERMEDICAL SUPPLIES LTD..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   BONE FIXATION SYSTEM
Proprietary Device Name:   ORTHOFIX MODULSYSTEM
Registered Establishment Name:  INTERMEDICAL SUPPLIES LTD..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FIXATION ROD
Proprietary Device Name:   ORTHOFIX TIBIAL/FEMORAL NAILING SYSTEM
Registered Establishment Name:  INTERMEDICAL SUPPLIES LTD..

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Last Modified: 29 April 2006
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