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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:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   RONGEUR (MULTIPLE BRANDS)
Registered Establishment Name:  ASANUS MEDIZINTECHNIK GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (VARIOUS TYPES)
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (MULTIPLE BRANDS)
Registered Establishment Name:  ASANUS MEDIZINTECHNIK GMBH.
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Proprietary Device Name:   VEHU-MEDICAL GMBH
Registered Establishment Name:  VEHU MEDICAL INSTRUMENTE GMBH.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   ACCESSORIES TO SYNPLUG
Registered Establishment Name:  ISOTIS NV.
Classification:   CEMENT OBTURATOR
Generic Device Name:   CEMENT RESTRICTOR
Proprietary Device Name:   SYSNPLUG
Registered Establishment Name:  ISOTIS NV.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   OSSATURA
Registered Establishment Name:  ISOTIS NV.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  Z.U. ENT..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPES OF AC POWERED MOTOR,ACCSRY,ATTACH SURGICAL ORTHOPAE.INST.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPE OF PNEUMATIC POWERED ORTHOPAE. SURGICAL INSTRMNTS & ACCESSORIES,ATT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF NAIL,BLADE,PLATE MULTI COMPONENT COMBO FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES OF INTRAMEDULLARY FIXATION RODS & ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS TYPES OF INVASIVE TRACTION COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPES OF METAL COMPOSITE MULTICOMP,NAIL,BLADE,BLADE FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF SINGLE COMPONENT NAIL,BLADE,PLATE COMBO FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS TYPES OF NONDEGRADABLE SOFT TISSUE FIXATION FASTENERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY ACE S.A.'R.L..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SOLATCH INTERNATIONAL.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   TCP BONE VOID FILLER
Proprietary Device Name:   TRIHA CERAMIQUES 100 PERCENT BTCP
Registered Establishment Name:  TEKNIMED SA.
Classification:   BONE CEMENT
Generic Device Name:   PMMA BONE CEMENT
Proprietary Device Name:   CEMFIX
Registered Establishment Name:  TEKNIMED SA.
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   PMMA BONE CEMENT
Proprietary Device Name:   SPINEFIX
Registered Establishment Name:  TEKNIMED SA.
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VAIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ORTHOMETRICS, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UHMWPE, PEGGED, UNCEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ORTHOMETRICS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ORTHOMETRICS, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SATURN ORTHOPEDICS.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW & FASTNER
Proprietary Device Name:   OSTEOSORB
Registered Establishment Name:  OSTEOMEDICS, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE ANCHOR, NON-SPINAL
Proprietary Device Name:   OPUS MAGNUM ANCHOR SYSTEM
Registered Establishment Name:  ARTHROCARE CORP..

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Last Modified: 29 April 2006
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