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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:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   NONE
Registered Establishment Name:  3D MEDICAL CONCEPTS, LLC.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   CAST CUTTER
Proprietary Device Name:   ELITE MEDICAL EQUIPMENT
Registered Establishment Name:  ELITE MEDICAL EQUIPMENT.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   HAND WHEEL
Proprietary Device Name:   HAND TRACTION WHEEL
Registered Establishment Name:  ELITE MEDICAL EQUIPMENT.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   LRTI BROACHES
Registered Establishment Name:  ELITE MEDICAL EQUIPMENT.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   ROI, MC+
Registered Establishment Name:  LDR MEDICAL.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   RESORBABLE CALCIUM SALT BONE FILLER
Proprietary Device Name:   BF+
Registered Establishment Name:  LDR MEDICAL.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   POSTERIOR LUMBAR SPINE SYSTEM
Proprietary Device Name:   EASYSPINE
Registered Establishment Name:  LDR MEDICAL.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  LDR MEDICAL.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   POSTERIOR LUMBAR SPINE SYSTEM
Proprietary Device Name:   EASYSPINE
Registered Establishment Name:  LDR MEDICAL.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   DRYVIEW SCOPE SHIELD
Proprietary Device Name:   DRYVIEW SCOPE SHIELD
Registered Establishment Name:  CANNUFLOW, INC..
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   THE X. PORTER
Registered Establishment Name:  THE X. PORTER.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   THE X. PORTER
Registered Establishment Name:  THE X. PORTER.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS WRENCHES, GUIDES, IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEIR VALVES & CONTROLS FRANCE.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEIR VALVES & CONTROLS FRANCE.
Classification:   TAP, BONE
Generic Device Name:   VARIOUS BONE TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEIR VALVES & CONTROLS FRANCE.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WEIR VALVES & CONTROLS FRANCE.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF HOLDER, NEEDLE, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  PHOEBUS MEDIZINTECHNIK GMBH.
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   VARIOUS TYPES OF GONIOMETERS AND INCLINOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  JTECH MEDICAL.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   VARIOUS TYPES OF DYNAMOMETERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  JTECH MEDICAL.
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   OSSEOUS BONE MILL
Registered Establishment Name:  BATCO - BRAZIL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  IKNO INDUSTRIES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  IKNO INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  IKNO INDUSTRIES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  IKNO INDUSTRIES.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF DORSAL INTRAMEDULLARY PLATES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEO VOLENTE ORTHOPAEDICS, LLC.
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF STERILE ACL FIXATION DEVICES
Proprietary Device Name:   RESOFIX BIOABSORBABLE EXPANSION BOLT
Registered Establishment Name:  AGENCY FOR MEDICAL INNOVATIONS GMBH.
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   XNRR TECHNOLOGIES
Registered Establishment Name:  XNRR TECHNOLOGIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   XNRR TECHNOLOGIES
Registered Establishment Name:  XNRR TECHNOLOGIES.
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   COMPRESSION HIP SCREW
Proprietary Device Name:   VIGOR COMPRESSION HIP SCREW SYSTEM
Registered Establishment Name:  RICOCHET INDUSTRIES, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   UNDERCAST PADDING
Proprietary Device Name:   UNDERCAST PADDING
Registered Establishment Name:  UNIVERSAL JOINT INTERNATIONAL CO., LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  WORLD MEDICAL DENT.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  WORLD MEDICAL DENT.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  WORLD MEDICAL DENT.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER
Registered Establishment Name:  WORLD MEDICAL DENT.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVERS
Proprietary Device Name:   ISSYS SCREWDRIVER & BLOCKER INSERTER
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   ISSYS ROD TEMPLATE
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   ISSYS AWL
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   TAP, BONE
Generic Device Name:   TAPS, BONE
Proprietary Device Name:   ISSYS TAPS (4.5, 5.5, 6.5, & 7.5MM)
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   INSTRUMENTS, COMPRESSION
Proprietary Device Name:   ISSYS COMPRESSORS (SMALL & LARGE)
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   BENDER
Generic Device Name:   ROD BENDERS
Proprietary Device Name:   ISSYS ROD BENDERS, FRENCH BENDER, IN-SITU BENDERS
Registered Establishment Name:  CUSTOM SPINE, INC..

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Last Modified: 29 April 2006
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