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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:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS DESIGNS OF SURGICAL SCISSORS
Proprietary Device Name:   SURGICAL MAGNUM WIRE SCISSORS
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   CARTS, FRAMES, WEIGHT, CORDS
Proprietary Device Name:   MEDICAL DEPOT
Registered Establishment Name:  MEDICAL DEPOT.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED
Generic Device Name:   BIO-TECHNOLOGY FEMORAL HEAD, HIP, CERAMIC-ZIRCONIUM
Proprietary Device Name:   BIO-TECHNOLOGY FEMORAL HEAD, HIP, CERAMIC-ZIRCONIUM
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   BIO-TECHNOLOGY POROUS COATED ACETABULAR CUP HIP
Proprietary Device Name:   BIO-TECHNOLOGY POROUS COATED ACETABULAR CUP HIP
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   BIOTECHNOLOGY POROUS COATED HIP STEM
Proprietary Device Name:   BIOTECHNOLOGY POROUS COATED HIP STEM
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   BIO-TECHNOLOGY USA HIP STEM
Proprietary Device Name:   BIO-TECHNOLOGY USA HIP STEM
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   MAXILLOFACIAL SCREW FIXATION BONE
Proprietary Device Name:   BIO-TECHNOLOGY BMB SCREW BUCOMAXILLO FACIAL
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   MAXILLOFACIAL BONE PLATE, FIXATION, BONE
Proprietary Device Name:   BIOTECHNOLOGY BMB PLATE BUCOMAXILLOFACIAL, FIXATION, BONE
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Generic Device Name:   SCREW PEDICULAR SYSTEM, FIXATION
Proprietary Device Name:   BIOTECHNOLOGY SPS I SCREW PEDICULAR SYSTEM, FIXATION
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, KNEE, HEMI-, TIBIAL, RESURFACING (UNCEMENTED)
Generic Device Name:   TIBIAL KNEE
Proprietary Device Name:   BIOTECHNOLOGY MDB III TIBIAL KNEE
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Generic Device Name:   HIP ENDOPROSTHESIS
Proprietary Device Name:   THB HIP ENDOPROSTHESIS (BIO-TECHNOLOGY)
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   PATELLAR KNEE
Proprietary Device Name:   BIO-TECHNOLOGY MBD PATELLAR KNEE
Registered Establishment Name:  BIO-TECHNOLOGY USA, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MEDICATE INDUSTRIES.
Classification:   ARTHROSCOPE
Generic Device Name:   ARHTROSCOPE & ACCESSORIES
Proprietary Device Name:   ARTHROJET SYSTEM
Registered Establishment Name:  HYDROCISION, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   SURGICAL INSTRUMENT, AC POWERED MOTORS AND ACC
Proprietary Device Name:   HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
Registered Establishment Name:  HYDROCISION, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   VARIOUS SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   VARIOUS SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   CERCLAGE, FIXATION
Generic Device Name:   VARIOUS SPINAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   CEMENT OBTURATOR
Generic Device Name:   VARIOUS INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   ORTHOPAEDIC INSTRUMENTS
Proprietary Device Name:   DISC WHISK
Registered Establishment Name:  STRYKER SPINE.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL FUSION DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL FIXATION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   SPINAL FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES AND SIZES OF TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  STRYKER SPINE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  AL.NOOR CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   NONE
Registered Establishment Name:  GAUTHIER BIOMEDICAL, INC..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   NONE
Registered Establishment Name:  GAUTHIER BIOMEDICAL, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  A&I INDUSTRIES LTD.,SHUNDE,FOSHAN.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   CAMCERAM TCP
Registered Establishment Name:  CAM IMPLANTS B.V..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   DYNASTAT
Proprietary Device Name:   THE DYNASTAT (MODEL NO.3)
Registered Establishment Name:  DYNASTAT BIOMECHANICS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SURGICAL SCISSORS
Proprietary Device Name:   M.A. ARAIN & BROTHERS (PVT) LTD.
Registered Establishment Name:  M.A.ARAIN & BROTHERS (PVT), LTD..
Classification:   SYSTEM, CEMENT REMOVAL EXTRACTION
Generic Device Name:   DENTAL INSTRUMENTS
Proprietary Device Name:   M.A. ARIAN & BROTHERS (PVT), LTD.
Registered Establishment Name:  M.A.ARAIN & BROTHERS (PVT), LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   KAWALITY MANUFACTURING CO.
Registered Establishment Name:  KAWALITY MANUFACTURING CO..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HOWMEDICA OSTEONICS CORP.

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Last Modified: 29 April 2006
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