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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:   APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Generic Device Name:   ANTERIOR SPINE BONE PLATE
Proprietary Device Name:   CASF (CONTOURED ANTERIOR SPINAL FIXATION) SYSYEM
Registered Establishment Name:  DEPUY SPINE, INC..
Classification:   PROSTHESIS, INTERVERTEBRAL DISC
Generic Device Name:   INTERVERTEBRAL DISC PROSTHESIS WITH RELATED INSTRUMENTATION
Proprietary Device Name:   CHARITE ARTIFICIAL DISC
Registered Establishment Name:  DEPUY SPINE, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS VACUUM BAG AND LOW MELT PLASTIC CAST SUPPORTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIONIX DEVELOPMENT CORP..
Classification:   INSTRUMENT, CAST REMOVAL, AC-POWERED
Generic Device Name:   POWERED CAST SAW
Proprietary Device Name:   NO PROPRIETARY NAME LISTED
Registered Establishment Name:  DEBUSK ORTHOPEDIC CASTING (DOC).
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS TYPES OF PLASTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DEBUSK ORTHOPEDIC CASTING (DOC).
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS, SIZES, STYLES & DESIGNS
Proprietary Device Name:   BAYLOR PELVIC TRACTION BELT
Registered Establishment Name:  TEXAS MEDICAL INDUSTRIES, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS SIZES OF TRACTION WEIGHTS; TRACTION CARTS
Proprietary Device Name:   CAST IRON WEIGHTS & HANGERS; TMI CART
Registered Establishment Name:  TEXAS MEDICAL INDUSTRIES, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   BUCK'S TRACTION DEVICE
Proprietary Device Name:   BUCK'S TRACTION DEVICE
Registered Establishment Name:  TEXAS MEDICAL INDUSTRIES, INC..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS MODELS OF MOTORS/ATTACH.VARIOUS STERILE/NON-STERILE ACCESSORIES
Proprietary Device Name:   BONE SCALPEL ACRYLO-OSTEOTOME
Registered Establishment Name:  MEDTRONIC POWERED SURGICAL SOLUTIONS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   ELECTRIC HIGH SPEED MOTOR & VARIOUS STERILE & NON STERILE ACCESSORIES
Proprietary Device Name:   MIDAS REX LEGENDS EHS SYSTEM
Registered Establishment Name:  MEDTRONIC POWERED SURGICAL SOLUTIONS.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS SIZES AND STYLES OF BONE SCREWS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARBOMEDICS, INC..
Classification:   PROSTHESIS, UPPER FEMORAL
Generic Device Name:   VARIOUS SIZES AND STYLES OF STERILE AND NON-STERILE HEMI-ARTHROPLASTY DEVICES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  CARBOMEDICS, INC..
Classification:   POSITIONER, SOCKET
Generic Device Name:   HEAD REST
Proprietary Device Name:   PRONE POSITIONER
Registered Establishment Name:  VOSS MEDICAL PRODUCTS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   POWERED HAND INSTRUMENTS
Proprietary Device Name:   POWERED HAND INSTRUMENTS
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   HIP DISTRACTION SYSTEM,HARDWARE
Proprietary Device Name:   HIP DISTRACTION SYSTEM,HARDWARE
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   NON-INVASIVE TRACTION COMPONENT
Proprietary Device Name:   NON-INVASIVE TRACTION COMPONENT
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   DYONICS EP-1 SHAVER SYSTEM
Proprietary Device Name:   DYONICS EP-1 SHAVER SYSTEM
Registered Establishment Name:  SMITH & NEPHEW, INC..
Classification:   HALTER, HEAD, TRACTION
Generic Device Name:   VARIOUS MODEL OF HEAD HALTERS
Proprietary Device Name:   HEAD HALTER
Registered Establishment Name:  TARTAN ORTHOPEDICS, LTD..
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  TARTAN ORTHOPEDICS, LTD..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  TARTAN ORTHOPEDICS, LTD..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   BUCKS TRACTION
Proprietary Device Name:   BUCKS TRACTION
Registered Establishment Name:  TARTAN ORTHOPEDICS, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   STRIPPER, SURGICAL
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   ARTHROSCOPE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   GAUGE, DEPTH
Generic Device Name:   DEPTH GAUGE
Proprietary Device Name:   DEPTH GAUGE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   WASHER, BOLT NUT
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   SCREW, FIXATION, BONE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   STARTER, BONE SCREW
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   AWL
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   TREPHINE
Generic Device Name:   TREPHINE
Proprietary Device Name:   TREPINE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   TAP, BONE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   PASSER, WIRE, ORTHOPEDIC
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   TWISTER, WIRE
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   CERCLAGE, FIXATION
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   WIRE, SURGICAL
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   GUIDE, DRILL, LIGAMENT
Generic Device Name:   GUIDE,DRILL,LIGAMENT
Proprietary Device Name:   GUIDE,DRILL,LIGAMENT
Registered Establishment Name:  SONTEC INSTRUMENTS, INC..
Classification:   STRIPPER, SURGICAL
Generic Device Name:   TENDON STRIPPERS
Proprietary Device Name:   TENDON STRIPPERS
Registered Establishment Name:  KING TOOL, INC..

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Last Modified: 29 April 2006
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