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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:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   K PLUS INTL.
Registered Establishment Name:  K PLUS INTERNATIONAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   K PLUS INTL.
Registered Establishment Name:  K PLUS INTERNATIONAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  K PLUS INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  K PLUS INTERNATIONAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   BOLAN TRADERS
Registered Establishment Name:  BOLAN TRADERS.
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS TYPES AND SIZES OF CAST COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  INTERCONTINENTAL MEDICAL IMPORTACAO E EXPORTACAO L.
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   TONGUE STRENGH MEASURING DEVICE
Proprietary Device Name:   IOPI (IOPI ORAL PERFORMANCE INSTRUMENT)
Registered Establishment Name:  IOPI NORTHWEST COMPANY, LLC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   PAK DICKLAS IMPEX
Registered Establishment Name:  PAK DICKLAS IMPEX.
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   PLGA MICROSPHERES
Proprietary Device Name:   PLGA MICROSPHERES
Registered Establishment Name:  UTHSC-HOUSTON-DEPT. OF ORTHOPEDICS.
Classification:   ARTHROSCOPE
Generic Device Name:   CANADA ENDOSCOPE
Proprietary Device Name:   CANADA ENDOSCOPE
Registered Establishment Name:  CANADA ENDOSCOPE CORPORATION.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  AMER TRADERS.
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   CALIPER
Registered Establishment Name:  AMER TRADERS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS, ORTHOPEDIC, SURGICAL#ORTHOPEDIC
Registered Establishment Name:  AMER TRADERS.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE#ORTHOPEDIC
Registered Establishment Name:  AMER TRADERS.
Classification:   RONGEUR
Generic Device Name:   HAND RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  UNITECH MEDIZINTECHNIK GMBH.
Classification:   COMPONENT, CAST
Generic Device Name:   UNDERCAST PADDING
Proprietary Device Name:   UNDERCAST PADDING
Registered Establishment Name:  MEDTECS (CAMBODIA) CORP., LTD..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SPINE SYSTEM
Proprietary Device Name:   UCR SPINAL SYSTEM
Registered Establishment Name:  SEASPINE, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   INTERBODY FIXATOR
Proprietary Device Name:   VERTE-STACK(TM)SPINAL SYSTEM
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH.
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR FIXATION DEVICE
Proprietary Device Name:   GAPP(TM) GRAFT CONTAINMENT DEVICE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE, VOID FILLER
Proprietary Device Name:   MASTERGRAFT(TM) BONE VOID FILLER
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH.
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL FUSION DEVICE
Proprietary Device Name:   TELAMON(TM)-P FUSION DEVICE, BOOMERANG(TM)-P FUSION DEVICE
Registered Establishment Name:  MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DILIGENT MEDICAL SERVICES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DILIGENT MEDICAL SERVICES.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES OF PROBES
Proprietary Device Name:   PROBE (MULTIPLE BRANDS)
Registered Establishment Name:  QUALITY CONCEPT (PVT) LTD..
Classification:   GENERATOR,SHOCK-WAVE,(FOR PAIN RELIEF)
Generic Device Name:   EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) PAIN RELIEF SYSTEM
Proprietary Device Name:   ORBASONE PAIN RELIEF SYSTEM
Registered Establishment Name:  ORTHOMETRIX, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   DENT-TECHNIK
Registered Establishment Name:  DENT-TECHNIK.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE FIXATION SCREW, CANNULATED COMPRESSION SCREW
Proprietary Device Name:   BOLD SCREW
Registered Establishment Name:  INTERMED APPLICATIONS S.A.R.L..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE FIXATION STAPLE
Proprietary Device Name:   SOLUSTAPLE
Registered Establishment Name:  INTERMED APPLICATIONS S.A.R.L..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   BONE FIXATION WIRE, SELF-TAPPING THREADED WIRE
Proprietary Device Name:   TAC'PIN
Registered Establishment Name:  INTERMED APPLICATIONS S.A.R.L..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   METATARSAL-PHALANGEAL ARTHRODESIS PLATE
Proprietary Device Name:   HALLU-PLATES (HALLU-C PLATE AND HALLU-S PLATE)
Registered Establishment Name:  INTERMED APPLICATIONS S.A.R.L..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   K-WIRE END PROTECTOR
Proprietary Device Name:   K-FIX
Registered Establishment Name:  INTERMED APPLICATIONS S.A.R.L..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   BONE TOOL
Registered Establishment Name:  ORTHOPEDIC SCIENCES, INC.
Classification:   SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
Generic Device Name:   PEDICLE SCREW FIXATION SYSTEM
Proprietary Device Name:   OUTOLOGOUS SPINAL FIXATION DEVICE
Registered Establishment Name:  ORTHOPEDIC SCIENCES, INC.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   CUSTOM-HIP,S-BONE,TITANIUM-HIP TOOL,TSY SHOULDER PLATE IMPLANT
Registered Establishment Name:  ORTHOPEDIC SCIENCES, INC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS DESIGNS OF SURGICAL SCISSORS
Proprietary Device Name:   SURGICAL MAGNUM WIRE SCISSORS
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS TYPES OF SOFT TISSUE FASTENERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF NONPOWERED DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF SOFT TISSUE FASTENERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ETS LASSERTEUX.

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Last Modified: 29 April 2006
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