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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:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   UHMWPOLYETHLENE, PROSTHEIS, HIP, ACETUBULAR COMPONENT
Proprietary Device Name:   UHMWPOLYETHLENE, PROSTHEIS, HIP, ACETUBULAR COMPONENT
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   ACETABULAR, PROSTHESIS, HIP,ACETABULAR COMPONENT, MEAAL,CEMENTED
Proprietary Device Name:   ACETABULAR, PROSTHESIS, HIP,ACETABULAR COMPONENT, MEAAL,CEME
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   MULTIPLE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   CONDYLAR, IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Proprietary Device Name:   CONDYLAR, IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   NAIL, BONE
Proprietary Device Name:   NAIL, BONE
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   CAP, BONE
Generic Device Name:   BONE-CAP BONE
Proprietary Device Name:   BONE-CAP BONE
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   THREADED PIN
Proprietary Device Name:   THREADED PIN
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   PROSTHESIS, WRIST, 2 PART METAL-PLASTIC ARTICULATION, SEMI-CONSTRAINED
Generic Device Name:   PROSTHESIS,WRIST, 2 PART METAL-PLASTIC, ARTICULATION SEMI-CONSTRAINED
Proprietary Device Name:   PROSTHESIS,WRIST, 2 PART METAL-PLASTIC, ARTICULATION SEMI-CO
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
Generic Device Name:   ARTICULATION, PROSTHESIS, WRIST, 3 PART METAL PLASTIC-METAL ARTICULATION, SEMI-C
Proprietary Device Name:   ARTICULATION, PROSTHESIS, WRIST, 3 PART METAL PLASTIC-METAL
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   ACETABULAR, PROSTHESIS, HIP, ACETABULAR COMPONENT METAL, NOT-CEMENTED
Proprietary Device Name:   ACETABULAR, PROSTHESIS, HIP, ACETABULAR COMPONENT METAL, NOT
Registered Establishment Name:  BIO-LOK INTL., INC..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR I
Proprietary Device Name:   EXTRACTOR I
Registered Establishment Name:  THE ANSPACH EFFORT, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE ANCHOR
Proprietary Device Name:   ANSPACH ANCHOR SYSTEM
Registered Establishment Name:  THE ANSPACH EFFORT, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   PNEUMATIC DRILL SYSTEM LUBRICATION SYSTEM
Proprietary Device Name:   ANSPACH AUTOLUBE II
Registered Establishment Name:  THE ANSPACH EFFORT, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   WRIST HAND HOLDER
Proprietary Device Name:   WRIST HAND HOLDER
Registered Establishment Name:  MARAMED PRECISION CORP..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Registered Establishment Name:  VILEX, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VILEX, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   PELVIC TRACTION UNIT
Proprietary Device Name:   DUOTRAC
Registered Establishment Name:  BAGRAD.
Classification:   TEMPLATE
Generic Device Name:   SUPRAFOIL
Proprietary Device Name:   SUPRAFOIL
Registered Establishment Name:  S. JACKSON, INC..
Classification:   WRENCH
Generic Device Name:   CYLINDER WRENCH
Proprietary Device Name:   7-Sep
Registered Establishment Name:  SEVEN HARVEST INTL. IMPORT & EXPORT.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   NO COMMON NAME LISTED
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  AUSTIN & ASSOC., INC..
Classification:   CALIPER
Generic Device Name:   BODY FAT TESTERS
Proprietary Device Name:   FUTREX-5000, 5000A, FUTREX-6100/XL
Registered Establishment Name:  FUTREX, INC..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   SPINAL FIXATION DEVICE
Proprietary Device Name:   EBI OMEGA 21 SYSTEM
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   SPINAL FIXATION DEVICE
Proprietary Device Name:   EBI OMEGA 21 SYSTEM
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   SPINAL FIXATION DEVICE
Proprietary Device Name:   EBI OMEGA 21 SYSTEM
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   SPINAL FIXATION DEVICE
Proprietary Device Name:   EBI OMEGA 21 SYSTEM
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   STAINLESS STEEL BONE SCREWS
Proprietary Device Name:   IQL BASIC FRAGMENT SCREW SET/SMALL FRAGMENT SET/MINI FRAGMENT SET
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   STAINLESS STEEL BONE PLATES
Proprietary Device Name:   PLATE, FIXATION, BONE#ORTHOPEDIC
Registered Establishment Name:  BIOMET SPAIN ORTHOPAEDICS S.L..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINTS
Registered Establishment Name:  EBI, L.P..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST REMOVAL INSTRUMEAT
Registered Establishment Name:  EBI, L.P..
Classification:   COMPONENT, CAST
Generic Device Name:   ACCESSORIES CAST COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  EBI, L.P..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLT NUT WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF SEMI-CONSTRAINED HIP PROSTHESES(METAL CEMENT ACET COMPON)
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF BONE FIXATION NAILS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
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-NEW BEDFORD.
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
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-NEW BEDFORD.
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-NEW BEDFORD.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF FIXATION BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   VARIOUS TYPES OF SMOOTH FIXATION PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEPUY-NEW BEDFORD.

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Last Modified: 29 April 2006
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