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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:   WASHER, BOLT NUT
Generic Device Name:   VARIOUS BOLTS AND NUTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   SCREWDRIVERS, WRENCHES, TAPS, GUIDE PINS, ETC.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Generic Device Name:   PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS (RONGEURS)
Proprietary Device Name:   MULTIPLE (RONGEURS)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   EXTRACTOR
Generic Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Proprietary Device Name:   MULTIPLE (DRIVER-EXTRACTORS)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   CEMENT OBTURATOR
Generic Device Name:   CEMENT RESTRICTOR
Proprietary Device Name:   TCR, PCR, SHADOW CR, THREADED CR
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Generic Device Name:   THOMPSON
Proprietary Device Name:   THOMPSON TYPE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   MUELLER
Proprietary Device Name:   MUELLER TYPE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   INTERBODY FIXATOR
Proprietary Device Name:   VERTE-SPAN SPINAL SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   STAPLE, FIXATION, BONE
Generic Device Name:   STAPLE
Proprietary Device Name:   DYNAMIC COMPRESSION STAPLE SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Generic Device Name:   METALLIC BONE FIXATION DEVICE
Proprietary Device Name:   TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ORTHOSIS, SPINAL INTERVERTEBRAL FUSION
Generic Device Name:   SPINAL FUSION DEVICE
Proprietary Device Name:   INTERFIX TM THREADED FUSION DEVICE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   MULTI-AXIAL SCREW
Proprietary Device Name:   ALPHA POSTERIOR SPINAL SYSTEM
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   IMPACTOR
Generic Device Name:   IMPACTOR
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   BENDER
Generic Device Name:   VARIOUS BENDERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   FORK
Generic Device Name:   FORK, FORK HAMMER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PUSHER, SOCKET
Generic Device Name:   SOCKET
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   PROSTHESIS, INTERVERTEBRAL DISC
Generic Device Name:   INTERVERTEBRAL DISC PROSTHESIS
Proprietary Device Name:   BRYAN TOTAL CERVICAL DISC,PRESTIGE CERVICAL DISC,MAVERICK TOTAL DISC REPLACEMENT
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   MULTIPLE (SCISSORS)
Proprietary Device Name:   MULTIPLE (SCISSORS)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   COUNTERSINK
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   PLATE AND SCREW COMPRESSION DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   WRENCH
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC WRENCHES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER, ORTHOPEDIC
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   TAMP
Generic Device Name:   MULTPLE TAMPS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   ACCESSORIES,ARTHROSCOPIC
Generic Device Name:   ARTHROSCOPE
Proprietary Device Name:   ARTHROSCOPE
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   INSTRUMENT, BENDING OR CONTOURING
Generic Device Name:   VARIOUS ROD BENDERS
Proprietary Device Name:   ROD BENDER
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)
Proprietary Device Name:   MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   MULTIPLE (DEPTH GAUGES)
Proprietary Device Name:   MULTIPLE (DEPTH GAUGES)
Registered Establishment Name:  WARSAW ORTHOPEDIC, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   ADAPTORS
Proprietary Device Name:   FRACTURE FRAME ADAPTORS
Registered Establishment Name:  HILL-ROM, INC..
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   POLY-L-LACTIC ACID/POLYGLYCOLIC ACID PLATES
Proprietary Device Name:   LACTOSORB TRAUMA PLATING SYSTEM
Registered Establishment Name:  BIOMET, INC..
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   POLY-L-LACTIC ACID/POLYGLYCOLIC ACID SCREWS
Proprietary Device Name:   LACTOSORB TRAUMA PLATING SYSTEM
Registered Establishment Name:  BIOMET, INC..
Classification:   CORKSCREW
Generic Device Name:   FEMORAL HEAD REMOVER
Proprietary Device Name:   FEMORAL HEAD REMOVER
Registered Establishment Name:  BIOMET, INC..
Classification:   AWL
Generic Device Name:   VARIOUS TYPES OF AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   TREPHINE
Generic Device Name:   BLACKBURN TREPHINE
Proprietary Device Name:   BLACKBURN TREPHINE
Registered Establishment Name:  BIOMET, INC..
Classification:   SET, HOLLOW MILL
Generic Device Name:   HOLLOW MILL SET
Proprietary Device Name:   HOLLOW MILL SET
Registered Establishment Name:  BIOMET, INC..
Classification:   INSTRUMENT, COMPRESSION
Generic Device Name:   COMPRESSION DEVICE
Proprietary Device Name:   COMPRESSION DEVICE
Registered Establishment Name:  BIOMET, INC..
Classification:   SKID, BONE
Generic Device Name:   VARIOUS TYPES OF BONE SKIDS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOMET, INC..
Classification:   PUNCH, FEMORAL NECK
Generic Device Name:   MOORE HOLLOW CHISEL
Proprietary Device Name:   MOORE HOLLOW CHISEL
Registered Establishment Name:  BIOMET, INC..

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Last Modified: 29 April 2006
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