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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:   GONIOMETER, NONPOWERED
Generic Device Name:   UNI-LEVEL INCLINOMETER
Proprietary Device Name:   UNI-LEVEL INCLINOMETER
Registered Establishment Name:  NEWLY RISEN INDUSTRIAL LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  DARLEYS SURGICAL CO..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  DARLEYS SURGICAL CO..
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  DARLEYS SURGICAL CO..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  DARLEYS SURGICAL CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SGS EXPORT INTL..
Classification:   TAP, BONE
Generic Device Name:   TAP, BONE
Proprietary Device Name:   SMARTSCREW,BIOSORB,BIOCUFF,DUET
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR, DILATOR
Proprietary Device Name:   SMARTSCREW,IMPACT,THE WEDGE
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   SMARTNAIL,SMARTPIN
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, HARD TISSUE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   ABSORBABLE FIXATION PIN
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   BIOABSORBABLE SOFT TISSUE FIXATION DEVICE
Proprietary Device Name:   BIOSCUFF SCREW AND WASHER
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BIOABSORBABLE BONE FIXATION SCREW
Proprietary Device Name:   SMARTSCREW, NUGEN FX, BIOSORB ENDOBROW SCREW, BIOSORBFX SCREW, BIOSORBPDX
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   PROBE
Generic Device Name:   ARTHROSCOPIC PROBE
Proprietary Device Name:   MENSICUS ARROW
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   SMARTSCREW
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   IMPACTOR, MANUAL INSTALLATION DEVICE FOR IMPLANTS
Proprietary Device Name:   CMF TACK GUN, CROSSBOW, BANKART TACK
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   SMARTPIN
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   SMARTSCREW
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   SMARTSCREW,BIOCUFF,THE WEDGE, BIOSORB
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPIC MANUAL INSTRUMENTS
Proprietary Device Name:   LINVATEC MASTER ARTHROSCOPY SET: CONTAINS GRASPERS.SUTURE PASSERS,SUTURE CUTTERS
Registered Establishment Name:  CONMED LINVATEC BIOMATERIALS.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V..
Classification:   COMPONENT, CAST
Generic Device Name:   CAST COMPONENT
Proprietary Device Name:   CAST COMPONENT
Registered Establishment Name:  DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   BUCKS TRACTION
Proprietary Device Name:   BUCKS TRACTION
Registered Establishment Name:  DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   CASPER TYPE ORTHOPEDIC DISTRACTOR (VARIOUS TYPES)
Proprietary Device Name:   CASPER TYPE ORTHOPEDIC DISTRACTOR
Registered Establishment Name:  SIGNUS MEDIZINTECHNIK GMBH.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   INSTRUMENTS
Registered Establishment Name:  SIGNUS MEDIZINTECHNIK GMBH.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   KAINOS
Registered Establishment Name:  SIGNUS MEDIZINTECHNIK GMBH.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   PEDICLE SCREW SYSTEM
Proprietary Device Name:   CONKLUSION PEDICLE SCREW SYSTEM
Registered Establishment Name:  SIGNUS MEDIZINTECHNIK GMBH.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT
Proprietary Device Name:   MULTIPLE TETRIS SPINAL IMPANT
Registered Establishment Name:  SIGNUS MEDIZINTECHNIK GMBH.
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   RIGID TELESCOPE
Proprietary Device Name:   SOHNIKS
Registered Establishment Name:  SOHNIKS ENDOSCOPY, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   STRAUMANN EXTRAORAL IMPLANT SYSTEM
Registered Establishment Name:  INSTITUT STRAUMANN AG.
Classification:   PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Generic Device Name:   INTERSPINOUS PROCESS DISTRACTION SYSTEM
Proprietary Device Name:   X STOP INTERSPINOUS PROCESS DISTRACTION SYSTEM
Registered Establishment Name:  ST. FRANCIS MEDICAL TECHNOLOGIES, INC..
Classification:   CEMENT OBTURATOR
Generic Device Name:   OBTURATOR
Proprietary Device Name:   BIOPREP CEMENT OBTURATOR
Registered Establishment Name:  STRYKER IRELAND LTD..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   SYNTHETIC BONE GRAFT MATERIAL
Proprietary Device Name:   OSSIFORM
Registered Establishment Name:  UNICARE BIOMEDICAL, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEUR, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   THRU CUT PUNCH RONGEUR
Registered Establishment Name:  M-P MFG., INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES
Proprietary Device Name:   MULTIPLE BRANDS
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   SPACER, CEMENT
Generic Device Name:   VARIOUS TYPES OF CEMENT SPACERS
Proprietary Device Name:   SPACER, CEMENT (MULTIPLE BRANDS)
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Generic Device Name:   VARIOUS TYPES OF METAL HEMI-FEMORAL HIP PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) LTD..
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF METAL,POLY,CEMENTED,UNCEMENTED,CONTRAINED HIP PROSTH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY (IRELAND) LTD..

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Last Modified: 29 April 2006
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