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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:   AWL
Generic Device Name:   ORTHOPEDIC AWL
Proprietary Device Name:   AWL
Registered Establishment Name:  T.A.G. MEDICAL PRODUCTS.
Classification:   PROBE
Generic Device Name:   ORTHOPEDIC PROBE
Proprietary Device Name:   VARIOUS PROBES
Registered Establishment Name:  T.A.G. MEDICAL PRODUCTS.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC GRASPERS, GUIDES AND PUNCHS
Proprietary Device Name:   VARIOUS GRASPERS, GUIDES AND PUNCHS
Registered Establishment Name:  T.A.G. MEDICAL PRODUCTS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC SCISSORS
Proprietary Device Name:   VARIOUS SCISSORS
Registered Establishment Name:  T.A.G. MEDICAL PRODUCTS.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   LUMBAR TRACTION UNIT
Proprietary Device Name:   LUMBAR-TRACT
Registered Establishment Name:  W.S. ROTHBAND & CO., LTD..
Classification:   ARTHROSCOPE
Generic Device Name:   ARTHROSCOPIC PUMP AND ACCESSORIES
Proprietary Device Name:   ARTHRO-SURGIMAT
Registered Establishment Name:  W.O.M. WORLD OF MEDICINE AG.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   NONE
Registered Establishment Name:  K.T. SURGICO (PVT), LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   ELECTRIC-AC POWERED MANICURE/PEDICURE SET
Proprietary Device Name:   MACOR MANICURE/PEDICURE SET, JUNIOR
Registered Establishment Name:  ARISE DIFFUSION SA.
Classification:   HOLDER, NEEDLE; ORTHOPEDIC
Generic Device Name:   VARIOUS TYPES OF NEEDLE HOLDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  YDM CORP..
Classification:   GAUGE, DEPTH
Generic Device Name:   VARIOUS TYPES OF DEPTH GAUGES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  YDM CORP..
Classification:   BONE MILL
Generic Device Name:   VARIOUS TYPES OF BONE MILLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  YDM CORP..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   ULNAR, KIENBOCK, RADIAL PLATES & OSTEOTOMY DEVICES
Proprietary Device Name:   RAYHACK BONE PLATES AND OSTEOTOMY SYSTEMS
Registered Establishment Name:  CREATIVE MEDICAL DESIGNS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   BOSS
Registered Establishment Name:  BOSS INSTRUMENTS, LTD..
Classification:   RONGEUR
Generic Device Name:   RONGEUR-KERRISON
Proprietary Device Name:   BOSS
Registered Establishment Name:  BOSS INSTRUMENTS, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   ATHLE SURGICO
Registered Establishment Name:  TUESDAY MORNING PARTNERS, LTD..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   BIOLOGICAL INGROWTH ANATOMIC HIP STEM, FEMORAL STEMS, ACETABULAR CUPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Generic Device Name:   HIP JOINT METAL/POLYMER SEMI-CONSTRAINED UNCEMENTED PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR CEMENTED OR UNCEMENTED PR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, METALLIC AND NON-COLLAPSIBLE
Generic Device Name:   VARIOUS TYPES AND SIZES OF INTRAMEDULLARY NAILS, PINS, AND SETS CONTAINING VARIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   SCREW, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   TEMPLATE
Generic Device Name:   VARIOUS TYPES OF TEMPLATES AND GAUGE SETS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF SLIDING AND NON-SLIDING BONE NAILS & NAIL/PLATE COMBI
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   IMPLANT, FIXATION DEVICE, SPINAL
Generic Device Name:   VARIOUS TYPES AND SIZES OF SPINAL FIXATION DEVICES AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   VARIOUS TYPES AND SIZES OF PROXIMAL FEMORAL FIXATION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS TYPES AND SIZES OF PARTIALLY CONSTRAINED TOTAL KNEE PROSTHESES & ACCESSO
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS TYPES AND SIZESOF STERILE ACETABULAR CUPS AND SHELLS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   HIP JOINT FEMORAL(HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE PLATES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   VARIOUS PLASTIC PATELLAR SURFACE REPLACEMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES AND SIZES OF INTRAMEDULLARY NAILS, PINS, AND SETS CONTAINING VARIO
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONES SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER MANUFACTURING B.V..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  INSTRATEK, INC..
Classification:   STARTER, BONE SCREW
Generic Device Name:   HAND HELD INSTRUMENTS
Proprietary Device Name:   HAND HELD INSTRUMENTS
Registered Establishment Name:  INSTRATEK, INC..
Classification:   PIN, FIXATION, THREADED
Generic Device Name:   K WIRE
Proprietary Device Name:   GUIDE WIRE
Registered Establishment Name:  INSTRATEK, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   SCALPEL BLADE
Proprietary Device Name:   MORTONS NEUROMA/TRIGGER FINGER KIT 4058(A), 1052
Registered Establishment Name:  INSTRATEK, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BIT
Proprietary Device Name:   DRILL BIT 10327 (R)
Registered Establishment Name:  INSTRATEK, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   TITANIUM CANNULATED BONE SCREW
Proprietary Device Name:   TITANIUM CANNULATED BONE SCREW 14XXX
Registered Establishment Name:  INSTRATEK, INC..
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   DEPTH GAUGE/COUNTERSINK 10405
Registered Establishment Name:  INSTRATEK, INC..

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Last Modified: 29 April 2006
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