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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:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC (HEMOSTAT)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  R.N.T. INDUSTRY.
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   DYNAMIC AZIAL FIXATION SYSTEM
Proprietary Device Name:   ORTHOFIX MODULSYSTEM
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   UNREAMED TIBIAL NAIL SYSTEM
Proprietary Device Name:   ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   DYNAMIC AXIAL FIXATION SYSTEM
Proprietary Device Name:   ORTHOFIX MODULSYSTEM
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE FOR CLINICAL USE
Proprietary Device Name:   AGILITY STERI-KIT
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   DISTRACTION INSTRUMENT
Proprietary Device Name:   AGILITY STERI-KIT
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE SYSTEM
Proprietary Device Name:   ORTHOFIX MIOT PLATING SYSTEM
Registered Establishment Name:  ORTHOFIX SRL.
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHER, BOLT, NUT
Proprietary Device Name:   WASHER, BOLT, NUT
Registered Establishment Name:  EMAS COMPANY,LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   INVERTABOD; ORTHOPOD
Proprietary Device Name:   INVERTABOD; ORTHOPOD
Registered Establishment Name:  ORTHOPOD, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   INVERTABOD; ORTHOPOD
Proprietary Device Name:   INVERTABOD; ORTHOPOD
Registered Establishment Name:  BRILHANTE CO., INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MICRO-FRANCE
Registered Establishment Name:  MEDTRONIC XOMED INSTRUMENTATION S.A.S..
Classification:   RONGEUR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MICRO-FRANCE
Registered Establishment Name:  MEDTRONIC XOMED INSTRUMENTATION S.A.S..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   M.826 TENDON STRIPPER
Proprietary Device Name:   MICRO-FRANCE
Registered Establishment Name:  MEDTRONIC XOMED INSTRUMENTATION S.A.S..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MICRO-FRANCE
Registered Establishment Name:  MEDTRONIC XOMED INSTRUMENTATION S.A.S..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MICRO-FRANCE
Registered Establishment Name:  MEDTRONIC XOMED INSTRUMENTATION S.A.S..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   NEEDLE HOLDERS,ORTHOPEDIC (HEMOSTAT)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BUTI SONS INTL..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATES AND SCREWS
Proprietary Device Name:   BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL CURGERY
Registered Establishment Name:  BIOPLATE, INC..
Classification:   TAP, BONE
Generic Device Name:   TAP, BONE
Proprietary Device Name:   TAP, BONE
Registered Establishment Name:  BIOPLATE, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHER, BOLT, NUT
Proprietary Device Name:   WASHER, BOLT, NUT
Registered Establishment Name:  KAZAN MEDICAL INSTRUMENTS PLANT JOINT STOCK COMPAN.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BONE BURR
Proprietary Device Name:   BONE BURR
Registered Establishment Name:  KAZAN MEDICAL INSTRUMENTS PLANT JOINT STOCK COMPAN.
Classification:   TEMPLATE
Generic Device Name:   BENDING TEMPLATE
Proprietary Device Name:   BENDING TEMPLATE
Registered Establishment Name:  PAUL PESCHKE GMBH.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   ROD HOLDER
Proprietary Device Name:   ROD HOLDER
Registered Establishment Name:  PAUL PESCHKE GMBH.
Classification:   AWL
Generic Device Name:   AWL / ALL DIFFERENT
Proprietary Device Name:   AWL
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   TWISTER, WIRE
Generic Device Name:   PROBE
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   INSTRUMENT, COMPRESSION (PLIERS)
Proprietary Device Name:   INSTRUMENT, COMPRESSION (PLIERS)
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   TAP, BONE
Generic Device Name:   TAP, BONE
Proprietary Device Name:   TAP, BONE
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   LENOX MACLAREN BONE FRAGMENTOR
Registered Establishment Name:  LENOX-MACLAREN SURGICAL CORP..
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   CALIPER
Registered Establishment Name:  LONG YUE CAST-PRESS CO., LTD..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   AUSTIN MOORE HIP;THOMPSON HIP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
Generic Device Name:   ROPER TUKE ELBOW
Proprietary Device Name:   ROPER TUKE ELBOW
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, TENDON, PASSIVE
Generic Device Name:   PASSIVE TENDON PROSTHESIS
Proprietary Device Name:   THE CORIFIX LIGAMENT ANCHOR
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
Proprietary Device Name:   THE C-FIT FEMORAL HIP SYSTEM
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   THE CORIFIX DYNAMIC HIP SCREW SYSTEM
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS (ANTROLATERAL/ANTERIOR)
Proprietary Device Name:   CORIN SPINAL SYSTEM
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL INTERLAMINAL FIXATION ORTHOSIS (NONPEDICLE POSTERIOR)
Proprietary Device Name:   CORIN SPINAL SYSTEM
Registered Establishment Name:  CORIN MEDICAL, LTD..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   CORIN TAPER-FIT TOTAL HIP SYSTEM
Proprietary Device Name:   CORIN TAPER-FIT TOTAL HIP SYSTEM
Registered Establishment Name:  CORIN MEDICAL, LTD..

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Last Modified: 29 April 2006
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