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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:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS TYPES OF PROSTHESIS DRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   TEMPLATE
Generic Device Name:   DEYERLE FEMORAL TEMPLATE
Proprietary Device Name:   DEYERLE FEMORAL TEMPLATE
Registered Establishment Name:  BIOMET, INC..
Classification:   COUNTERSINK
Generic Device Name:   BONE SCREW COUNTERSINK
Proprietary Device Name:   BONE SCREW COUNTERSINK
Registered Establishment Name:  BIOMET, INC..
Classification:   TAP, BONE
Generic Device Name:   VARIOUS TYPES OF BONE SCREW TAPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   TAMP
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   APPLIER, CERCLAGE
Generic Device Name:   PARHAM BAND CLAMP
Proprietary Device Name:   PARHAM BAND CLAMP
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS TYPES OF BENOING INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   BENDER
Generic Device Name:   BRACE BENDING IRON
Proprietary Device Name:   BRACE BENDING IRON
Registered Establishment Name:  BIOMET, INC..
Classification:   BRACE, DRILL
Generic Device Name:   VARIOUS TYPES OF BRACE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   BUNNELL TENDON STRIPPER
Proprietary Device Name:   BUNNELL TENDON STRIPPER
Registered Establishment Name:  BIOMET, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  BIOMET, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   VARIOUS TYPES OF TRACTION SPLINTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTION BELT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   VARIOUS TYPES OF NON-POWERED, NON-PENETRATING HIP TRACTION UNITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS TYPES OF HALTERS, HEAD, TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS TYPES OF TRACTION (CART, REAME, CORD, WEIGHT) ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   STANMORE TOTAL KNEE
Proprietary Device Name:   STANMORE TOTAL KNEE
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   OSSOTOME
Proprietary Device Name:   OSSOTOME
Registered Establishment Name:  BIOMET, INC..
Classification:   PROTRACTOR
Generic Device Name:   POCKET PROTRACTOR
Proprietary Device Name:   POCKET PROTRACTOR
Registered Establishment Name:  BIOMET, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   BONE SCREW DEPTH GAUGE
Proprietary Device Name:   BONE SCREW DEPTH GAUGE
Registered Establishment Name:  BIOMET, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS TYPES OF BOLTS, NUTS, AND WASHERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   FILE
Generic Device Name:   ORTHOPEDIC BONE FILE
Proprietary Device Name:   ORTHOPEDIC BONE FILE
Registered Establishment Name:  BIOMET, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF BURR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   IMPACTOR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC IMPACTORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC EXTRACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   VARIOUS TYPES OF PROXIMAL FEMORAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   VARIOUS TYPES OF CONDYLAR BLADE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   PARHAM BAND
Proprietary Device Name:   PARHAM BAND
Registered Establishment Name:  BIOMET, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   VARIOUS TYPES OF THREADED PINS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   COMPONENT, TRACTION, INVASIVE
Generic Device Name:   VARIOUS TYPES OF SKELETAL TRACTION
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, WRIST, 2 PART METAL-PLASTIC ARTICULATION, SEMI-CONSTRAINED
Generic Device Name:   CFV WRIST SYSTEM
Proprietary Device Name:   CFV WRIST SYSTEM
Registered Establishment Name:  BIOMET, INC..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   VARIOUS TYPES OF GONIOMETER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   CALIPER
Generic Device Name:   VARIOUS TYPES OF CALIPER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, CONSTRAINED, METAL/METAL OR METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE AND NON-STERILE TOTAL SHOULDERS
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED
Generic Device Name:   CERAMIC HEAD COMPONENT
Proprietary Device Name:   CERAMIC HEAD COMPONENT
Registered Establishment Name:  BIOMET, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS STERILE & NON-STERILE INTRAMDULLARY PINS
Registered Establishment Name:  BIOMET, INC..

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Last Modified: 29 April 2006
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