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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:   WRENCH
Generic Device Name:   WRENCHES
Proprietary Device Name:   ISSYS WRENCHES (TORQUE & COUNTER TORQUE)
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   ISSYS PROBES (WIDE & NARROW), PEDICLE SOUNDER
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   ISSYS FIXED&RATCHET HANDLES,ROD PUSHER,CAM-COUPLER&ATTACHMENT,ROCKER,HEAD ADJUST
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   ISSYS PEDICLE SCREW
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL INTERLAMINAL FIXATION ORTHOSIS
Proprietary Device Name:   ISSYS PEDICLE SCREW SYSTEM
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   PEDICLE SCREW SPINAL SYSTEM
Proprietary Device Name:   ISSYS PEDICLE SCREW SYSTEM
Registered Establishment Name:  CUSTOM SPINE, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  ZONA INDUSTRIES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  ZONA INDUSTRIES.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  ZONA INDUSTRIES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER
Registered Establishment Name:  ZONA INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  MEDI CIVIC SURGICAL INSTRUMENTS COMPANY.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  MEDI CIVIC SURGICAL INSTRUMENTS COMPANY.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  MEDI CIVIC SURGICAL INSTRUMENTS COMPANY.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  MEDI CIVIC SURGICAL INSTRUMENTS COMPANY.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED
Generic Device Name:   METAL ACETABULAR SHELLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  EXEL PLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   INSTRUMENTS
Proprietary Device Name:   MAXLOCK
Registered Establishment Name:  ORTHOHELIX SURGICAL DESIGNS, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   ORTHOPEDIC PLATES AND SCREWS
Proprietary Device Name:   MAXLOCK
Registered Establishment Name:  ORTHOHELIX SURGICAL DESIGNS, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   POSTERIOR OCCIPITOCERVICAL FIXATION
Proprietary Device Name:   CERVO-LINK
Registered Establishment Name:  A-SPINE ASIA, CO., LTD.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   NECK TRACTION FIXER WITH MAGNETS,AND NECK TRACTION FIXER WITHOUT MAGNETS
Proprietary Device Name:   NECK TRACTION FIXER WITH MAGNETS,AND NECK TRACTION FIXER WITHOUT MAGNETS
Registered Establishment Name:  BEIJING DAXIANG NEW MATERIALS & TECHNOLOGY CO..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ALLEZ SPINE PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALLEZ SPINE, LLC.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ALLEZ SPINE PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALLEZ SPINE, LLC.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ALLEZ SPINE PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALLEZ SPINE, LLC.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ALLEZ SPINE PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALLEZ SPINE, LLC.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   SPINAL FIXATION SYSTEM
Proprietary Device Name:   ALLEZ SPINE PEDICLE SCREW SYSTEM
Registered Establishment Name:  ALLEZ SPINE, LLC.
Classification:   COMPONENT, CAST
Generic Device Name:   UNDER CAST PADDING
Proprietary Device Name:   UNDER CAST PADDING
Registered Establishment Name:  MEDLINE MANUFACTURING AND SERVICES LLC.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS SIZES AND STYLES FOR DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF TEMPLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTEGRA LIFESCIENCES CORPORATION.
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   ANGIOGRAPHIC INFLATION DEVICE
Proprietary Device Name:   DOLPHIN INFLATION SYSTEM
Registered Establishment Name:  SEDAT.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF DORSAL INTRAMEDULLARY PLATES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DVO EXTREMITY SOLUTIONS, LLC.
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   STAPLE
Proprietary Device Name:   MEMODYN STAPLE
Registered Establishment Name:  B R I (BIO RECHERCHES INNOVATIONS).
Classification:   PROSTHESIS, INTERVERTEBRAL DISC
Generic Device Name:   TOTAL ARTIFICIAL DISC
Proprietary Device Name:   SPINAL KINETICS CERVICAL DISC
Registered Establishment Name:  SPINAL KINETICS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDICS MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   SPINAL KINETICS CERVICAL DISC INSTRUMENTS
Registered Establishment Name:  SPINAL KINETICS, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   ACCORD CABLE SYSTEM
Proprietary Device Name:   ACCORD CABLE SYSTEM
Registered Establishment Name:  STRAITS ORTHOPAEDICS SDN BHD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SINUS TARSI IMPLANT
Proprietary Device Name:   HYPROCURE
Registered Establishment Name:  GRAMEDICA.
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   SPINAL COLUMN ANALYSIS SYSTEM
Proprietary Device Name:   CMS10,CMS20,CMS-HS
Registered Establishment Name:  ZEBRIS MEDICAL GMBH.
Classification:   PROSTHESIS, HIP, CONSTRAINED, METAL
Generic Device Name:   HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD.
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD.

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Last Modified: 29 April 2006
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