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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:   REAMER
Generic Device Name:   VARIOUS TYPES OF REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC RONGEUR
Registered Establishment Name:  BIOMET, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS ORTHOPEDIC WIRE PASSERS
Registered Establishment Name:  BIOMET, INC..
Classification:   PUSHER, SOCKET
Generic Device Name:   CUP POSITIONING AND AIMING DEVICE
Proprietary Device Name:   CUP POSITIONING AND AIMING DEVICE
Registered Establishment Name:  BIOMET, INC..
Classification:   CRIMPER, PIN
Generic Device Name:   DEE FIXATION CLAMP
Proprietary Device Name:   DEE FIXATION CLAMP
Registered Establishment Name:  BIOMET, INC..
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC SCREWDRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, UPPER FEMORAL
Generic Device Name:   VARIOUS TYPES OF FEMORAL HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   MEURIG WILLIAMS PLATE
Proprietary Device Name:   MEURIG WILLIAMS PLATE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   FINN TOTAL KNEE
Proprietary Device Name:   FINN TOTAL KNEE
Registered Establishment Name:  BIOMET, INC..
Classification:   SYSTEM, CEMENT REMOVAL EXTRACTION
Generic Device Name:   ULTRASONIC SURGICAL EQUIPMENT
Proprietary Device Name:   ULTRADRIVE
Registered Establishment Name:  BIOMET, INC..
Classification:   TUBE, CEMENT VENTILATION
Generic Device Name:   VENT TUBING
Proprietary Device Name:   VENT TUBING
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS TYPES OF MANUAL CAST REMOVEL INSTRUMENTS.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE AND NON-STERILE TOTAL ELBOWS.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP[ PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS AND CERAMIC HEAD.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP, MODULAR HEADS, ANDACETABULAR PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   BIO-GROOVE HA
Proprietary Device Name:   BIO-GROOVE HA
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
Generic Device Name:   TOTAL TOE
Proprietary Device Name:   TOTAL TOE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   BIO-MODULAR SHOULDER, BI-ANGULAR SHOULDER
Proprietary Device Name:   BIO-MODULAR SHOULDER, BI-ANGULAR SHOULDER
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   VARIOUS TYPES OF FEMORAL TOTAL HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYEPS OF ELECTRICAL POWERED SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   HARPOON SUTURE ANCHOR
Proprietary Device Name:   HARPOON SUTURE ANCHOR
Registered Establishment Name:  BIOMET, INC..
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   FIXATION PIN OR ROD
Proprietary Device Name:   LACTO BONE PIN
Registered Establishment Name:  BIOMET, INC..
Classification:   BONE CEMENT
Generic Device Name:   PMMA BONE CEMENT
Proprietary Device Name:   PALACOS GENERATION 4
Registered Establishment Name:  BIOMET, INC..
Classification:   PROBE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   MENISCAL STAPLE
Proprietary Device Name:   LACTOSORB MENISCAL REPAIR DEVICE
Registered Establishment Name:  BIOMET, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   VARIOUS TYPES OF LACTOSORB STERILE & NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE & NON-STERILE ELBOW COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS FOR STERILE & NON-STERILE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE & NON-STERILE SHOULDER COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS INSTRUMENTS, CEMENT GUN INSERTER APPLICATORS, TEMPLATES, GAGE SETS
Proprietary Device Name:   ORTHOPEDIC INSTRUMENT SET, PROVISIONAL TRIAL PROSTHESIS, CEMENTING EQUIPMENT
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, FEMORAL, RESURFACING
Generic Device Name:   VARIOUS RESURFACING FEMORAL HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   BROACH
Generic Device Name:   VARIOUS TYPES OF BROACHS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE AND NON-STERILE SHOULDER PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF STERILE AND NON-STERILE SHOULDER PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS
Proprietary Device Name:   FREEDOM CONSTRAINED LINER
Registered Establishment Name:  BIOMET, INC..

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Last Modified: 29 April 2006
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