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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:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   VARIOUS TYPES OF MARKING HOOKS
Proprietary Device Name:   ARTHREX MARKING HOOK
Registered Establishment Name:  ARTHREX, INC..
Classification:   REAMER
Generic Device Name:   VARIOUS SIZES CORING REAMERS AND RELATED ITEMS
Proprietary Device Name:   ARTHREX CORING REAMER
Registered Establishment Name:  ARTHREX, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   SHOULDER HOLDER
Proprietary Device Name:   SHOULDER HOLDER
Registered Establishment Name:  ARTHREX, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS STERILE BIOABSORBABLE SUTURE ANCHORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIUOS DEPTH GAUGES
Proprietary Device Name:   GAUGE
Registered Establishment Name:  ARTHREX, INC..
Classification:   PROTRACTOR
Generic Device Name:   PROTRACTOR FOR CLINICAL USE
Proprietary Device Name:   MEASURING MARLER
Registered Establishment Name:  ARTHREX, INC..
Classification:   CALIPER
Generic Device Name:   SIZING BLOCK
Proprietary Device Name:   GRAFT SIZING BLOCK
Registered Establishment Name:  ARTHREX, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE SUBSTITUTE
Proprietary Device Name:   HATRIC, BONE SUBSTITUTE FOR OPENING WEDGE OSTEOTOMIES
Registered Establishment Name:  ARTHREX, INC..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   UNIVERS TOTAL SHOULDER,PROSTHESIS,SEMI-CONTRAINED,METAL/NON-POROUS,CEMENTED VARI
Proprietary Device Name:   UNIVERS SHOULDER
Registered Establishment Name:  ARTHREX, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   PROSTHESIS,SHOULDER,HEMI-,HUMERAL,METALLIC UNCEMENTED
Proprietary Device Name:   UNIVERS SHOULDER
Registered Establishment Name:  ARTHREX, INC..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   APPLIER, CERCLAGE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   CERCLAGE KIT FOR ORTHOPEDIC USES
Proprietary Device Name:   ARTHREX CERCLAGE KIT
Registered Establishment Name:  ARTHREX, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   OBTURATORS, SHEATHS
Proprietary Device Name:   ARTHREX INSTRUMENTS
Registered Establishment Name:  ARTHREX, INC..
Classification:   STAPLE, ABSORBABLE
Generic Device Name:   STAPLE
Proprietary Device Name:   ARTHREX BIO-TRANSFIX
Registered Establishment Name:  ARTHREX, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   FIXATION PIN
Proprietary Device Name:   ARTHREX CHONDRAL DART
Registered Establishment Name:  ARTHREX, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   GRAFT HARVESTING KIT
Proprietary Device Name:   ARTHREX GRAFT HARVESTING KIT
Registered Establishment Name:  ARTHREX, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   HARVESTING SAW
Proprietary Device Name:   ARTHREX CIRCULAR HARVESTING SAW
Registered Establishment Name:  ARTHREX, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL (VARIOUS SIZE DRILL BITS)
Proprietary Device Name:   ARTHREX DRILL (VARIOUS SIZE DRILL BITS)
Registered Establishment Name:  ARTHREX, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE SCREWS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  ARTHREX, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   ARTHREX OSTEOTOMY PLATES
Registered Establishment Name:  ARTHREX, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   BONE STAPLE
Proprietary Device Name:   ARTHREX STAPLE
Registered Establishment Name:  ARTHREX, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   BELT, PELVIC, TRACTION
Proprietary Device Name:   BELT, PELVIC, TRACTION
Registered Establishment Name:  FLORIDA MFG. CORP..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   COMPONENT, TRACTION, NON-INVASIVE
Proprietary Device Name:   COMPONENT, TRACTION, NON-INVASIVE
Registered Establishment Name:  FLORIDA MFG. CORP..
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Proprietary Device Name:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Registered Establishment Name:  FLORIDA MFG. CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  LINVATEC CORP..
Classification:   GAUGE, DEPTH
Generic Device Name:   DRILL GUIDE
Proprietary Device Name:   ACL/PLC SYSTEM
Registered Establishment Name:  LINVATEC CORP..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   GUIDEWIRES,VARIOUS SIZES
Proprietary Device Name:   HYPERFLEX FLEXIBLE GUIDEWIRE
Registered Establishment Name:  LINVATEC CORP..
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  LINVATEC CORP..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   BADGER DRILL BIT
Registered Establishment Name:  LINVATEC CORP..
Classification:   TAP, BONE
Generic Device Name:   BONE TAP,VARIOUS SIZES
Proprietary Device Name:   STANDARD INTERFERENCE SCREW TAP
Registered Establishment Name:  LINVATEC CORP..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURRS
Proprietary Device Name:   HALL STERILE BURRS
Registered Establishment Name:  LINVATEC CORP..
Classification:   SYSTEM, CEMENT REMOVAL EXTRACTION
Generic Device Name:   CEMENT EXTRACTION SYSTEM
Proprietary Device Name:   HALL SEG-CES SEGMENTAL CEMENT EXTRACTION SYSTEM
Registered Establishment Name:  LINVATEC CORP..
Classification:   WASHER, BOLT NUT
Generic Device Name:   WASHERS
Proprietary Device Name:   LINVATEC SPIKED & FLAT WASHERS
Registered Establishment Name:  LINVATEC CORP..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   SUTURE ANCHOR
Proprietary Device Name:   BIO-ANCHOR ABSORBABLE SUTURE ANCHOR
Registered Establishment Name:  LINVATEC CORP..

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Last Modified: 29 April 2006
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