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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:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  PANORAMA INTL..
Classification:   PROSTHESIS, LIGAMENT
Generic Device Name:   LARS LIGAMENT
Proprietary Device Name:   LARS LIGAMENT
Registered Establishment Name:  LARS SA.
Classification:   SET, HOLLOW MILL
Generic Device Name:   LARS TITANIUM SCREW
Proprietary Device Name:   LARS TITANIUM SCREW
Registered Establishment Name:  LARS SA.
Classification:   STAPLE DRIVER
Generic Device Name:   LARS STABLE DRIVER
Proprietary Device Name:   LARS STABLE DRIVER
Registered Establishment Name:  LARS SA.
Classification:   SCREWDRIVER
Generic Device Name:   LARS SCREWDRIVER
Proprietary Device Name:   LARS SCREWDRIVER
Registered Establishment Name:  LARS SA.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   LARS BONE/FIXATION STABLE
Proprietary Device Name:   LARS BONE/FIXATION STABLE
Registered Establishment Name:  LARS SA.
Classification:   LIGAMENTS AND TENDONS, SYNTHETIC
Generic Device Name:   LIGAMENTS AND TENDONS, SYNTHETIC
Proprietary Device Name:   LIGAMENTS AND TENDONS, SYNTHETIC
Registered Establishment Name:  LARS SA.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   LARS TIBIAL GUIDE
Proprietary Device Name:   LARS TIBIAL GUIDE
Registered Establishment Name:  LARS SA.
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   LARS DRILL GUIDE
Proprietary Device Name:   LARS DRILL GUIDE
Registered Establishment Name:  LARS SA.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   GOTFRIED PC. C.P.
Proprietary Device Name:   GOTFRIED PC. C.P.
Registered Establishment Name:  EFRATGO, LTD. HI TECH BIO-SURGICAL.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   PORD DEVICE
Proprietary Device Name:   PORD DEVICE
Registered Establishment Name:  EFRATGO, LTD. HI TECH BIO-SURGICAL.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   GOTFRIED PH (PHYSIOLOGICAL HIP) NAIL
Proprietary Device Name:   GOTFRIED PH (PHYSIOLOGICAL HIP) NAIL
Registered Establishment Name:  EFRATGO, LTD. HI TECH BIO-SURGICAL.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  EUROCUT, LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   BOLD SCREW
Registered Establishment Name:  NEWDEAL S.A..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE FIXATION STAPLE
Proprietary Device Name:   UNI-CLIP STAPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS
Proprietary Device Name:   TAC PIN
Registered Establishment Name:  NEWDEAL S.A..
Classification:   TEMPLATE
Generic Device Name:   TRIAL IMPLANT
Proprietary Device Name:   TEMPLATE FOR CLINICAL USE (MULTIPLE BRANDS)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   MEASURER
Registered Establishment Name:  NEWDEAL S.A..
Classification:   BIT, DRILL
Generic Device Name:   CANNULATED DRILL, DRILL, DRILL GUIDE
Proprietary Device Name:   BIT, DRILL (MULTIPLE BRANDS)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   IMPACTOR (MULTIPLE BRANDS)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   TAP, BONE
Generic Device Name:   TAP
Proprietary Device Name:   TAP, BONE (MULTIPLE BRANDS)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   STAPLE DRIVER
Generic Device Name:   COMPRESSION FORCEPS
Proprietary Device Name:   UNI-CLIP SPREADING FORCEPS
Registered Establishment Name:  NEWDEAL S.A..
Classification:   SCREWDRIVER
Generic Device Name:   CANNULATED SCREWDRIVER, INTERNAL SCREWDRIVER, EXTERNAL SCREWDRIVER
Proprietary Device Name:   SCREWDRIVER (MULTIPLE BRANDS)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   POSITIONER, SOCKET
Generic Device Name:   HOLDER, REALEASER, LEVER
Proprietary Device Name:   VILADOT LEVER
Registered Establishment Name:  NEWDEAL S.A..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   METATORSAL-PHALANGEAL ARTHRODESISPLATE
Proprietary Device Name:   HALLU PLATES (HALLU-C PLATE AND HALLU-S PLATE)
Registered Establishment Name:  NEWDEAL S.A..
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  NEWDEAL S.A..
Classification:   AWL
Generic Device Name:   TREPHINE,AWL
Proprietary Device Name:   TREPHINE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   BENDER
Generic Device Name:   BENDER
Proprietary Device Name:   PLATE BENDER
Registered Establishment Name:  NEWDEAL S.A..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   METATARSAL HEAD EXTRACTOR
Registered Establishment Name:  NEWDEAL S.A..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS SMOOTH FIXATION PINS AND WIRES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SURGICAL INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   AC POWERED ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY NAIL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NEWDEAL S.A..
Classification:   PUMP, VACUUM, ELECTRIC, SUCTION-TYPE ELECTRODE
Generic Device Name:   ELECTRODE
Proprietary Device Name:   ZMI
Registered Establishment Name:  ZMI ELECTRONICS, LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   AMBULATORY
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED
Registered Establishment Name:  SPINAL TRACTION PRODUCTS, LLC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   UNIPOLAR MODULAR HEMI-HIP SYSTEM
Proprietary Device Name:   FIXION UNIPOLAR MODULAR HEMI HIP SYSTEM (FIXION UH)
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXING BOWL
Proprietary Device Name:   CONFIDENCE CEMENT MIXING BOWL
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   DYNAMIC HIP SCREW SYSTEM
Proprietary Device Name:   FIXION DYNAMIC HIP SCREWW SYSTEM (FIXION DHS)
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   INTRAMEDULLARY FIXATION ROD
Proprietary Device Name:   FIXION INTRAMEDULLARY NAILING SYSTEM
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..

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Last Modified: 29 April 2006
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