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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:   BONE MILL
Generic Device Name:   BIO COMP MINI MILL
Proprietary Device Name:   BIO COMP MINI MILL
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   ROD, FIXATION, INTRAMEDULLARY
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   SCREWDRIVER
Generic Device Name:   ORTHOPEDIC SCREWDRIVER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   TAP, BONE
Generic Device Name:   TAP, BONE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF DRILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   FILE
Generic Device Name:   VARIOUS TYPES OF FILES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF KNIVES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES OF SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES OF SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   VARIOUS TYPES OF STRIPPERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES OF WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF WIRE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   WRENCH
Generic Device Name:   WRENCH
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Generic Device Name:   CONDYLAR FIXATION DEVICE
Proprietary Device Name:   BERARDUCCI CONDYLAR POSITION SET
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WALTER LORENZ SURGICAL, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   BUCKS TRACTION; TRACTION UNIT, BED, OVER DOOR
Proprietary Device Name:   APPARATUS, TRACTION, NON-POWERED
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  SCOTT SPECIALTIES, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   VARIOUS TYPES AND MODELS OF PERSONAL GROOMING SCISSORS
Proprietary Device Name:   VARIOUS TYPES AND MODELS OF PERSONAL GROOMING SCISSORS
Registered Establishment Name:  BILL CLARK CO..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   BARNES FEMORAL LENGTHENING DEVICE
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  PIEDMONT SPORTS MEDICINE COMPLEX.
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPE SHEATH, CANNULA, OR SLEEVE
Proprietary Device Name:   HIGH FLOW ARTHROSHEATH
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, INC..
Classification:   PROBE
Generic Device Name:   ARTHROSCOPIC PROBE
Proprietary Device Name:   FMS PROBE
Registered Establishment Name:  FUTURE MEDICAL SYSTEMS, INC..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   TOTAL KNEE SYSTEM
Proprietary Device Name:   EXACTECH CEMENTED TOTAL KNEE SYSTEM
Registered Establishment Name:  EXACTECH, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH
Proprietary Device Name:   GAUGE, DEPTH
Registered Establishment Name:  EXACTECH, INC..
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   REAMER
Registered Establishment Name:  EXACTECH, INC..
Classification:   BROACH
Generic Device Name:   BROACH
Proprietary Device Name:   BROACH
Registered Establishment Name:  EXACTECH, INC..
Classification:   BIT, DRILL
Generic Device Name:   BIT, DRILL
Proprietary Device Name:   BIT, DRILL
Registered Establishment Name:  EXACTECH, INC..
Classification:   EXTRACTOR
Generic Device Name:   EXTRACTOR
Proprietary Device Name:   EXTRACTOR
Registered Establishment Name:  EXACTECH, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SCREW, FIXATION, BONE
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  EXACTECH, INC..
Classification:   BRACE, DRILL
Generic Device Name:   BRACE, DRILL
Proprietary Device Name:   BRACE, DRILL
Registered Establishment Name:  EXACTECH, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Proprietary Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Registered Establishment Name:  EXACTECH, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Proprietary Device Name:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Registered Establishment Name:  EXACTECH, INC..
Classification:   TEMPLATE
Generic Device Name:   TEMPLATE
Proprietary Device Name:   TEMPLATE
Registered Establishment Name:  EXACTECH, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   CERAMIC FEMORAL HEAD COMPONENTS
Proprietary Device Name:   EXACTECH ZIRAMIC FEMORAL HEADS
Registered Establishment Name:  EXACTECH, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Proprietary Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Registered Establishment Name:  EXACTECH, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Proprietary Device Name:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Registered Establishment Name:  EXACTECH, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   INSTRUMENTS, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENTS
Proprietary Device Name:   ACCUDRIVER & ACCESSORIES & ATTACHMENTS
Registered Establishment Name:  EXACTECH, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   EXACTECH HIP & KNEE ORTHOPEDIC SURGICAL INSTRUMENTS
Registered Establishment Name:  EXACTECH, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   MODULAR DRILLS BITS
Proprietary Device Name:   EXACTECH STERILE MODULAR DRILL BITS
Registered Establishment Name:  EXACTECH, INC..

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Last Modified: 29 April 2006
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