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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, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES OF HIPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE STAPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHER, BOLT, NUT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF FEMORAL COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
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:  HOWMEDICA OSTEONICS CORP.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   ARTIFICIAL HIP IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   ARTIFICIAL HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS HIP IMPLANTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
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:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   HUMERAL STEMS/HEADS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS CABLE SYSTEM COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS TYPES OF CEMENT OBTURATORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   ARTIFICIAL HIP STEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION SCREW, CANNULATED COMPRESSION SCREW
Proprietary Device Name:   BOLD SCREW
Registered Establishment Name:  CHARLES PERY ET CIE S.A..
Classification:   FIXATION ACCESSORY
Generic Device Name:   FIXATION ACCESSORY
Proprietary Device Name:   FIXATION ACCESSORY
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENDING INSTRUMENTS
Proprietary Device Name:   MULTIPLE TYPES OF BENDING INSTRUMENTS
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   CUTTER, WIRE
Generic Device Name:   CUTTER, WIRE (VARIOUS TYPES)
Proprietary Device Name:   CUTTER, WIRE (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   TWISTER, WIRE
Generic Device Name:   TWISTER, WIRE (VARIOUS TYPES)
Proprietary Device Name:   TWISTER, WIRE (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   APPARATUS, TRACTION, NON-POWERED (VARIOUS TYPES)
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL (VARIOUS TYPES)
Proprietary Device Name:   BRACE, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   REAMER
Generic Device Name:   REAMER (VARIOUS TYPES)
Proprietary Device Name:   REAMER (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER (VARIOUS TYPES)
Proprietary Device Name:   SCREWDRIVER (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   RONGEUR
Generic Device Name:   RONGEUR (VARIOUS TYPES)
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH (VARIOUS TYPES)
Proprietary Device Name:   GAUGE, DEPTH (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL (VARIOUS TYPES)
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (VARIOUS TYPES)
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  ORTHO MEDICAL GMBH IMPLANTS.
Classification:   TEMPLATE
Generic Device Name:   ANATOMICAL MODELS
Proprietary Device Name:   DEMETECH ANATOMICAL MODELS
Registered Establishment Name:  DEMETECH CORP..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Registered Establishment Name:  BONTEMPI CHIRURGISCHE INSTRUMENTE OHG.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   VARIOUS TYPES OF SCISSORS
Registered Establishment Name:  BONTEMPI CHIRURGISCHE INSTRUMENTE OHG.
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   VARIOUS TYPES OF RONGEURS
Registered Establishment Name:  BONTEMPI CHIRURGISCHE INSTRUMENTE OHG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CHESS SYSTEM
Proprietary Device Name:   CANICA DESIGN, INC.
Registered Establishment Name:  CANICA DESIGN, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   PLATE AND SCREW CERVICAL SPINAL FIXATION SYSTEM
Proprietary Device Name:   SPECTRUM CERVICAL SPINAL SYSTEM
Registered Establishment Name:  SPINAL INNOVATIONS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   HOOK, ROD AND SCREW SPINAL FIXATION SYSTEM
Proprietary Device Name:   SHADOW SPINAL SYSTEM
Registered Establishment Name:  SPINAL INNOVATIONS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  KITAMURA CORP..
Classification:   PROSTHESIS, KNEE, HEMI-, FEMORAL (UNCEMENTED)
Generic Device Name:   OSTEOCHONDRAL IMPLANT
Proprietary Device Name:   SALUCARTILAGE
Registered Establishment Name:  SALUMEDICA, L.L.C..

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Last Modified: 29 April 2006
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