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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, UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES OF EXTERNAL WRIST PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPES OF FIXATION APPLIANCES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS
Proprietary Device Name:   PATIENT MATCHED TITANIUM ALLOY TROCHLEA REPLACEMENT
Registered Establishment Name:  BIOMET, INC..
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS TYPES OF BONE GRAFT SUBSTITUTE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF HIP PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   EVACUATOR, VAPOR, CEMENT MONOMER
Generic Device Name:   CEMENTATION SYSTEM
Proprietary Device Name:   OPTIVAC CEMENTATION SYSTEM
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   VARIOUS TYPES OF SHOULDER PROSTHESES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPES OF ULTRASONIC BONE CUTTING INSTRUMENTS
Proprietary Device Name:   ULTRA-DRIVE 3
Registered Establishment Name:  BIOMET, INC..
Classification:   BONE CEMENT, ANTIBIOTIC
Generic Device Name:   VARIOUS TYPES OF BONE CEMENT
Proprietary Device Name:   PALACOS G BONE CEMENT WITH GENTAMICIN
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UHMWPE, PEGGED, UNCEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, MOBILE BEARING
Generic Device Name:   VARIOUS TYPES OF KNEE PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
Generic Device Name:   VARIOUS TYPES OF ELBOW PROSTHESIS
Proprietary Device Name:   MODULAR RADIAL HEAD
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS TYPES OF KNEE COMPONENTS
Proprietary Device Name:   ASCENT POROUS OPEN BOX PS FEMORAL COMPONENTS
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   VARIOUS TYPES OF STERILE HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Generic Device Name:   VARIOUS TYPES OF STERILE HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
Generic Device Name:   VARIOUS TYPES OF STERILE HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Generic Device Name:   VARIOUS TYPES OF STERILE HIP COMPONENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   VARIOUS SIZES OF NON-STERILE PENILE MOLDS
Proprietary Device Name:   PENLE MOLD
Registered Establishment Name:  COOK UROLOGICAL, INC..
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  COOK UROLOGICAL, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   HIP INSTRUMENTS, KNEE INSTRUMENTS, ORTHOPEDIC INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   REAMERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   AWL
Generic Device Name:   RC AWL
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   TAMP
Generic Device Name:   BONE TAMP
Proprietary Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   ORTHOPEDIC MANUAL / SURGICAL INSTRUMENT
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   ARTHROSCOPIC INSTRUMENT
Proprietary Device Name:   ARTHO
Registered Establishment Name:  MECTRA LABS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SURGICAL INSTRUMENTS
Proprietary Device Name:   INNOMED, INC. INSTRUMENTS FOR ORTHOPAEDIC SURGERY
Registered Establishment Name:  INNOMED CORP..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   HIP DISTRACTOR
Proprietary Device Name:   INNOMED, INC. HIP DISTRACTOR
Registered Establishment Name:  INNOMED CORP..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTORS
Proprietary Device Name:   INNOMED, INC. EXTRACTION INSTRUMENTS
Registered Establishment Name:  INNOMED CORP..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST CUTTING GUIDE AND CAST STAND
Proprietary Device Name:   INNOMED, INC. CAST CUTTING GUIDE AND CAST STAND
Registered Establishment Name:  INNOMED CORP..
Classification:   POSITIONER, SOCKET
Generic Device Name:   DAILY ACTIVITY ASSIST DEVICE
Proprietary Device Name:   SOCK STARTER
Registered Establishment Name:  THE VERNON CO..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   MENS OR LADIES PELVIC TRACTION BELT
Proprietary Device Name:   SAME
Registered Establishment Name:  ACCELERATED CARE PLUS CORP..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   TRACTION HEAD HALTER FOR MEN OR LADIES
Proprietary Device Name:   SAME
Registered Establishment Name:  ACCELERATED CARE PLUS CORP..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   MENS OR LADIES PELVIC TRACTION BELT
Proprietary Device Name:   SAME
Registered Establishment Name:  ACCELERATED CARE PLUS CORP..
Classification:   BIT, DRILL
Generic Device Name:   BONE DRILL
Proprietary Device Name:   BONE DRILL
Registered Establishment Name:  INTEGRA LIFESCIENCES CORP..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS TYPES OF PELVIC TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS TYPES OF HEAD HALTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  M-PACT WORLDWIDE, LLC..

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Last Modified: 29 April 2006
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