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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:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS MODELS OF FASTENERS
Proprietary Device Name:   KARL STORZ FASTENER
Registered Establishment Name:  KARL STORZ GMBH & CO. KG.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS MODELS OF ARTHROSCOPE AND ACCESSORIES
Proprietary Device Name:   KARL STORZ ARTHROSCOPE AND ACCESSORIES
Registered Establishment Name:  KARL STORZ GMBH & CO. KG.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS MODELS OF ORTHOPEDIC SURGICAL INSTRUMENT
Proprietary Device Name:   KARL STORZ ORTHOPEDIC SURGICAL INSTRUMENT
Registered Establishment Name:  KARL STORZ GMBH & CO. KG.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS BONE FIXATION SCREWS
Proprietary Device Name:   KARL STORZ FIXATION SCREW
Registered Establishment Name:  KARL STORZ GMBH & CO. KG.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   ARTHROSCOPY SHAVER SYSTEM
Proprietary Device Name:   KARL STORZ MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
Registered Establishment Name:  KARL STORZ GMBH & CO. KG.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   RECHARGABLE BATTERY
Proprietary Device Name:   STRENUMED SYSTEM 2000 REPLACEMENT BATTERY & EXTENDED RUN REPLACEMENT BATTERY
Registered Establishment Name:  STRENUMED, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM
Proprietary Device Name:   ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   BENDING AND CONTOURING INSTRUMENT
Proprietary Device Name:   ARTHROCARE AND ENTEC BENDING TOOL
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   DISPENSER, CEMENT
Generic Device Name:   CEMENT DISPENSER
Proprietary Device Name:   EZFLOW CEMENT DELIVERY SYSTEM
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 NONPOWERED DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   CEMENT, BONE, VERTEBROPLASTY
Generic Device Name:   PNNA BONE CEMENT
Proprietary Device Name:   PARALLAX ACRYLIC RESIN WITH TRACERS OR TRACERS TA
Registered Establishment Name:  ARTHROCARE CORP..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION ACCESSORIES
Proprietary Device Name:   TRACTION ACCESSORIES
Registered Establishment Name:  CHM.
Classification:   PROBE
Generic Device Name:   VARIOUS SIZES OF PROBES
Proprietary Device Name:   PROBE
Registered Establishment Name:  MEDGAL.
Classification:   RONGEUR
Generic Device Name:   RONGEURS
Proprietary Device Name:   RONGEURS
Registered Establishment Name:  REBSTOCK INSTRUMENTS GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW,BONE
Proprietary Device Name:   SURGIVAL
Registered Establishment Name:  SURGIVAL CO, S.A..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   PLATE,BONE
Proprietary Device Name:   SURGIVAL
Registered Establishment Name:  SURGIVAL CO, S.A..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   COPIOS BONE VOID FILLER
Registered Establishment Name:  KENSEY NASH CORP..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS MODELS OF NON-POWERED TRACTION APPARATUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TAIWAN AN I CO.,LTD..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   MODULAR KNEE PORSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION STAPLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
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 FRANCE S.A.S..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   VARIOUS TYPES OF NON-POROUS CALCIUM-PHOS METAL,POLY,UNCEMENT,SEMI-CONST,HIP PROS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF CEMENTED,NON-PROUS UNCEMENTED METAL,CERAM,POLY SEMI-CONST HIP
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY FRANCE S.A.S..
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PETER W. SEEH MEDICAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  PETER W. SEEH MEDICAL.
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   LUMBAR & CERVICAL TRACTION
Proprietary Device Name:   CARE REHAB LUMBAR, STARR CERVICAL, COMFORTRAC LUMBAR & CERVICAL
Registered Establishment Name:  CARE REHAB AND ORTHOPAEDIC PRODUCTS, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   BANDAGE SCISSORS
Proprietary Device Name:   KENTRON BANDAGE SCISSORS
Registered Establishment Name:  KENTRON HEALTH CARE, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   WIRE TWISTER
Proprietary Device Name:   TWISTER, WIRE
Registered Establishment Name:  AF INSTRUMENTE.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  AF INSTRUMENTE.
Classification:   PROSTHESIS, TENDON, PASSIVE
Generic Device Name:   OVAL ROD (SILICONE)
Proprietary Device Name:   SIL-TEC OVAL SHAPES
Registered Establishment Name:  TECHNICAL PRODUCTS, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   KNEE JOINT SYSTEM
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  HAYES MEDICAL, INC..

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Last Modified: 29 April 2006
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