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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:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   ULTIEM SPINAL PLATING SYSTEM
Registered Establishment Name:  ALTIVA CORP..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR CERVICAL PLATING SYSTEM
Proprietary Device Name:   CERVIEW ANTERIOR CERVICAL PLATING SYSTEM
Registered Establishment Name:  ALTIVA CORP..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   HYDRALOK SYSTEM
Registered Establishment Name:  ALTIVA CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE (MULTIPLE BRANDS)
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, SA.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   SOFT TISSUE FIXATION DEVICE
Proprietary Device Name:   ADHOC CLAW
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, SA.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW, FIXATION, BONE
Proprietary Device Name:   SCREW, FIXATION, BONE (MULTIPLE BRANDS)
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, SA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, SA.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   ROTATOR CUFF STERILE IMPLANT
Proprietary Device Name:   BIODHOC
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, SA.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE (MULTIPLE BRANDS)
Registered Establishment Name:  HEMODIA SA.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   PLATE, FIXATION, BONE
Registered Establishment Name:  MEDIN A.S..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  MEDIN A.S..
Classification:   BONE CEMENT
Generic Device Name:   VARIOUS STERILE BONE CEMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HERAEUS KULZER GMBH & CO. KG.
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   VARIOUS STERILE ANTIBIOTIC BONE CEMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HERAEUS KULZER GMBH & CO. KG.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS CEMENT MIXERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HERAEUS KULZER GMBH & CO. KG.
Classification:   DISPENSER, CEMENT
Generic Device Name:   VARIOUS CEMENT DISPENSER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HERAEUS KULZER GMBH & CO. KG.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   ANGIOTENSIN CONVERTING ENZYME TEST SYSTEM
Proprietary Device Name:   ACE REAGENT
Registered Establishment Name:  TRINITY BIOTECH, PLC.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   TRUNCAL ORTHOSIS
Proprietary Device Name:   SAFEHIP
Registered Establishment Name:  TYTEX, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SURJEX.
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SURJEX.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   BALL JOINT
Proprietary Device Name:   ALUMINA HEADS
Registered Establishment Name:  FOURNITURES HOSPITALIERES INDUSTRIE.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   FEMORAL STEM
Proprietary Device Name:   ESOP HA FEMORAL STEM
Registered Establishment Name:  FOURNITURES HOSPITALIERES INDUSTRIE.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   FEMORAL HEAD
Proprietary Device Name:   METALLIC FEMORAL HEAD
Registered Establishment Name:  FOURNITURES HOSPITALIERES INDUSTRIE.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   BIO-EUROLIG SCREW
Registered Establishment Name:  FOURNITURES HOSPITALIERES INDUSTRIE.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   HUMERAL NAIL
Proprietary Device Name:   TITANIUM TELEGRAPH HUMERAL NAIL
Registered Establishment Name:  FOURNITURES HOSPITALIERES INDUSTRIE.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  GARISH SURGICAL (PVT) LTD..
Classification:   PROBE
Generic Device Name:   SAME
Proprietary Device Name:   PROBE
Registered Establishment Name:  GARISH SURGICAL (PVT) LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   HIP JOINT PROSTHESES OR REPLACEMENT
Proprietary Device Name:   U1 HIP SYSTEM
Registered Establishment Name:  UNITED ORTHOPEDIC CORP..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTAI MEDICAL & HEALTH ARTICLES (SUZHOU) CO., LTD.
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DELTAI MEDICAL & HEALTH ARTICLES (SUZHOU) CO., LTD.
Classification:   TREPHINE
Generic Device Name:   BONE & MARROW COLLECTION SYSTEM
Proprietary Device Name:   BONE & MARROW COLLECTION SYSTEM
Registered Establishment Name:  BIOMEDICAL ENT., INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   NITINOL BONE STAPLES AND ACCESSORY INSTRUMENTS
Proprietary Device Name:   OSSTAPLE
Registered Establishment Name:  BIOMEDICAL ENT., INC..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   MOTION ANALYSIS SYSTEM (3D-DYNAMIC RANGE-OF-MOTION)
Proprietary Device Name:   3D-SPINE
Registered Establishment Name:  SKILL TECHNOLOGIES, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  MICROTEK MEDICAL, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   BAHO ARTHROSCOPE
Registered Establishment Name:  RUDOLF INNOVIEW GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   AWL
Registered Establishment Name:  TECHRON AG.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TECHRON AG.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TECHRON AG.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TECHRON AG.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   SCREW
Registered Establishment Name:  TECHRON AG.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TECHRON AG.

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Last Modified: 29 April 2006
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