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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:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   MARYAM TRADING
Registered Establishment Name:  MARYAM TRADING.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   MINIFIX
Proprietary Device Name:   FIXANO MINIFIX
Registered Establishment Name:  SMALL BONE INNOVATIONS INTERNATIONAL, SA.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   HUMERUS WIRES
Proprietary Device Name:   FIXANO HUMERUS WIRES
Registered Establishment Name:  SMALL BONE INNOVATIONS INTERNATIONAL, SA.
Classification:   PIN, FIXATION, SMOOTH
Generic Device Name:   BLOCK STOP WIRES
Proprietary Device Name:   FIXANO BLOCK STOP WIRES
Registered Establishment Name:  SMALL BONE INNOVATIONS INTERNATIONAL, SA.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTING SCISSORS WIRE PULLING FORCEPS
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   CALIPER
Generic Device Name:   CALIPERS USE
Proprietary Device Name:   TOWNLEY FEMUR CALIPER
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Generic Device Name:   HOOK HOLDER
Proprietary Device Name:   HOOK HOLDER
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   IMPACTOR
Generic Device Name:   DOUBLE ENDED IMPACTOR, IMPACTOR
Proprietary Device Name:   IMPACTOR
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC HOLDERS
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC (MULTIPLE BRANDS)
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ALL TYPE OF HANDLES, ACCESSOIRES,UNIVERSAL ADAPTORS,CHUCKS,CONNECTING ELEMENTS
Proprietary Device Name:   SOFT GRIP HANDLES & ACCESSOIRES
Registered Establishment Name:  MARIDA, MARIANNE DANIELS CHIR. INSTR..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE ANCHOR
Proprietary Device Name:   LI MEDICAL ULTRAFIX
Registered Establishment Name:  LI MEDICAL TECHNOLOGIES, INC..
Classification:   FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Generic Device Name:   BONE ANCHOR
Proprietary Device Name:   ROTOLOC
Registered Establishment Name:  LI MEDICAL TECHNOLOGIES, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   OVERDOOR TRACTION
Proprietary Device Name:   ENDURANCE
Registered Establishment Name:  ESSENTIAL MEDICAL SUPPLY, INC..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   HOLDER
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  BANZAI CORPORATION (PVT.), LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPIC SHAVER & ARTHROSCOPIC WAND
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VANGUARD MEDICAL CONCEPTS, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   BURR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VANGUARD MEDICAL CONCEPTS, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  VANGUARD MEDICAL CONCEPTS, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   LUMBAR REHABILITATION SYSTEM
Proprietary Device Name:   LTX 3000
Registered Establishment Name:  SPINAL DESIGNS INTL..
Classification:   INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
Generic Device Name:   CAST STAND
Proprietary Device Name:   IMP TURNSTILE CASTING STAND
Registered Establishment Name:  INNOVATIVE MEDICAL PRODUCTS, INC..
Classification:   FORK
Generic Device Name:   MANUAL SURGICAL INSTRUMENT
Proprietary Device Name:   DICKSON FRACTURE FORK
Registered Establishment Name:  INNOVATIVE MEDICAL PRODUCTS, INC..
Classification:   AWL
Generic Device Name:   AWL/SUTURE PASSER
Proprietary Device Name:   DEMAYO SUPERAWL
Registered Establishment Name:  INNOVATIVE MEDICAL PRODUCTS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   DEVICE USED IN THA TO MEASURE AND MAINTAIN LEG LENGTH
Proprietary Device Name:   EQUALIZER
Registered Establishment Name:  INNOVATIVE MEDICAL PRODUCTS, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH
Proprietary Device Name:   GAUGE, DEPTH
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   PROBE
Generic Device Name:   SAME
Proprietary Device Name:   PROBE ORTHOPEDIC
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   RONGEUR
Generic Device Name:   SAME
Proprietary Device Name:   RONGEUR ORTHPEDIC
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   SCREWDRIVER
Generic Device Name:   ORTHOPEDIC SCREW DRIVER
Proprietary Device Name:   SCREWDRIVER
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SAME
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   FILE
Generic Device Name:   SAME
Proprietary Device Name:   SURGICAL ORTHOPEDIC FILE
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   CUTTER, WIRE
Generic Device Name:   SAME
Proprietary Device Name:   CUTTER, WIRE
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   SAME
Proprietary Device Name:   SCREW, FIXATION, BONE
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   SAME
Proprietary Device Name:   HOLDER, NEEDLE; ORTHOPEDIC
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   KNIFE, ORTHOPEDIC
Generic Device Name:   SAME
Proprietary Device Name:   KNIFE, ORTHOPEDIC
Registered Establishment Name:  COMBINED INSTRUMENTS (PVT.), LTD..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, COMPOSITE/POLYMER
Generic Device Name:   VARIOUS STERILE, CEMENTED FEMORAL HIP COMPONENTS, STERILE
Proprietary Device Name:   H-120 CEMENTED HIP SYSTEM
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICUM-PHOSPHATE
Generic Device Name:   VARIOUS SIZES OF STERILE HA COATED FEMORAL HIP STEMS AND ACETABULAR CUPS AND REL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES OF STERILE CANCELLOUS BONE SCREWS AND RELATED NON-STERILE INSTRUME
Proprietary Device Name:   A-205 CANCELLOUS BONE SCREW
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   VARIOUS SIZES OF STERILE POROUS COATED FEMORAL HIP STEMS AND STERILE POROUS COAT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS STERILE FEMORAL KNEE,TIBIAL KNEE AND PATELLA KNEE COMPONETS AND RELATED
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.
Classification:   PROTRACTOR
Generic Device Name:   EXTRAMEDEDULLARY TIBIAL ALIGNMENT GUIDE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER TRABECULAR.

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Last Modified: 29 April 2006
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