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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:   ARTHROSCOPE
Generic Device Name:   STERILE BONE TAMPS
Proprietary Device Name:   SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   TAMP
Generic Device Name:   STERILE BONE TAMPS
Proprietary Device Name:   SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE SCREW FIXATION SYSTEM
Proprietary Device Name:   BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF STERILE & NON-STERILE IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT INJECTOR
Proprietary Device Name:   DISC-O-TECH CEMENT INJECTOR
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW FIXATION SYSTEM
Proprietary Device Name:   BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
Registered Establishment Name:  DISC-O-TECH MEDICAL TECHNOLOGIES, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SAQALAIN INTL..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AIRTRAC MSI., INC..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   INTERVERTEBRAL DISC
Proprietary Device Name:   LUNAR DISC
Registered Establishment Name:  MICRON PRECISION ENGINEERING, INC..
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL INTERVERTEBRAL IMPLANT-FUSION
Proprietary Device Name:   DYNAMIC GAGE
Registered Establishment Name:  MICRON PRECISION ENGINEERING, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW FIXATION
Proprietary Device Name:   ORTHOSIS, SPINAL PEDICLE FIXATION
Registered Establishment Name:  MICRON PRECISION ENGINEERING, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION SYSTEMS
Proprietary Device Name:   THE 4CIS SOLAR SPINE SYSTEM AND 4CIS LOW BACK SYSTEM/4CIS APOLLON SPINE SYSTEM
Registered Establishment Name:  SOLCO BIOMEDICAL CO., LTD..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   TRAUMA FIXATION PLATE SYSTEM
Proprietary Device Name:   SOLCO 4CIS GENERAL PLATE SYSTEM
Registered Establishment Name:  SOLCO BIOMEDICAL CO., LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   MANUAL ARTHROSCOPIC INSTRUMENTS
Proprietary Device Name:   ACUPUNCH
Registered Establishment Name:  AME INT'L..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  BIO SURGICAL INTL..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  NUVASIVE, INC..
Classification:   SYSTEM, FACET SCREW SPINAL DEVICE
Generic Device Name:   FACET SCREW
Proprietary Device Name:   NUVASIVE TRANSFACET/INTRAPEDICULAR SCREW
Registered Establishment Name:  NUVASIVE, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Registered Establishment Name:  NUVASIVE, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT DEVICE
Proprietary Device Name:   NUVASIVE MESH
Registered Establishment Name:  NUVASIVE, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE STANDARD SURGICAL INSTRUMENTS, STERILE AND NON-STERILE
Registered Establishment Name:  NUVASIVE, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL IMPLANTS
Proprietary Device Name:   NUVASIVE SPINAL SYSTEM, SPHERX
Registered Establishment Name:  NUVASIVE, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL IMPLANTS
Proprietary Device Name:   NUVASIVE SPINAL SYSTEM, SPHERX
Registered Establishment Name:  NUVASIVE, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL IMPLANTS
Proprietary Device Name:   NUVASIVE SPINAL SYSTEM, SPHERX
Registered Establishment Name:  NUVASIVE, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL IMPLANTS
Proprietary Device Name:   NUVASIVE SPINAL SYSTEM, SPHERX
Registered Establishment Name:  NUVASIVE, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  HILBRO INTERNATIONAL (PVT) LIMITED.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Registered Establishment Name:  HILBRO INTERNATIONAL (PVT) LIMITED.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   HIP CORE & BONE GRAFTING SYSTEM
Proprietary Device Name:   AV CORE SYSTEM
Registered Establishment Name:  MODULAR CUTTING SYSTEMS, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   GUIDANCE SYSTEM FOR PLACEMENT OF INTRAMEDULLARY ROD
Proprietary Device Name:   EUCLID REDUCTION & GUIDANCE SYSTEM
Registered Establishment Name:  MODULAR CUTTING SYSTEMS, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE STAPLE
Proprietary Device Name:   E.I.S STAPLE
Registered Establishment Name:  GROUPE LEPINE.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREWS
Proprietary Device Name:   E.I.S BONE SCREWS
Registered Establishment Name:  GROUPE LEPINE.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   ACI TAPERED REAMER
Registered Establishment Name:  ALBERTA CUSTOM INSTRUMENTS LTD..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   WIRE TWISTER
Registered Establishment Name:  ADAM MAIER CHIRURGISCHE INSTRUMENTE.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SCS-CLARIS
Proprietary Device Name:   MULTIPLE: ORTHOTEC, SCS CLARIS, SCS SPINAL SYSTEM, CLARIS
Registered Establishment Name:  ORTHOTEC, L.L.C..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SCS-CLARIS
Proprietary Device Name:   MULTIPLE: ORTHOTEC, SCS CLARIS, SCS SPINAL SYSTEM, CLARIS
Registered Establishment Name:  ORTHOTEC, L.L.C..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SCS-CLARIS
Proprietary Device Name:   MULTIPLE: ORTHOTEC, SCS CLARIS, SCS SPINAL SYSTEM
Registered Establishment Name:  ORTHOTEC, L.L.C..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SCS-CLARIS
Proprietary Device Name:   MULTIPLE: ORTHOTEC, SCS CLARIS, SCS SPINAL SYSTEM, CLARIS
Registered Establishment Name:  ORTHOTEC, L.L.C..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  A. HUSSAIN SURGICAL CORP..
Classification:   COMPONENT, CAST
Generic Device Name:   UNDERCAST PADDING
Proprietary Device Name:   UNDERCAST PADDING
Registered Establishment Name:  ANJI HUIFENG SURGICAL DRESSING CO., LTD.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR FIXATOR
Proprietary Device Name:   K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
Registered Establishment Name:  SPINEOLOGY, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   NONE
Registered Establishment Name:  SPINEOLOGY, INC..

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Last Modified: 29 April 2006
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