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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:   DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
Generic Device Name:   BONE PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS
Proprietary Device Name:   CFTU, CONSTANT-FORCE TRACTION UNIT
Registered Establishment Name:  PRO-ZOOICS RESEARCH ASSOCIATES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  DENTAL PLUS INCORPORATED.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  DENTAL PLUS INCORPORATED.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDWARE INTERNATIONAL.
Classification:   UNIT, TRACTION, HIP, NON-POWERED, NON-PENETRATING
Generic Device Name:   HIP HOLDER
Proprietary Device Name:   LATERAL POSITIONER
Registered Establishment Name:  CLEVELAND MEDICAL INC..
Classification:   RONGEUR
Generic Device Name:   VARIOUS TYPES OF RONGEURS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ASC MEDICAL CONSULTING.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ASC MEDICAL CONSULTING.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS
Proprietary Device Name:   TRACTION KITS / SETS - VARIOUS
Registered Establishment Name:  TYNOR ORTHOTICS, LTD..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS TYPES OF MANUAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS ACETABULAR REAMERS AND DRIVERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYMMETRY MEDICAL USA, INC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   UAMF INDUSTRIES
Registered Establishment Name:  UAMF INDUSTRIES.
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   UAMF INDUSTRIES
Registered Establishment Name:  UAMF INDUSTRIES.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS TYPES OF BITS
Proprietary Device Name:   DRILL BITS
Registered Establishment Name:  MEDVATION INCORPORATED.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  SPARTECH INSTRUMENTS & CO..
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  SPARTECH INSTRUMENTS & CO..
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  SPARTECH INSTRUMENTS & CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  SPARTECH INSTRUMENTS & CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  IMRAN BROTHERS INSTRUMENTS.
Classification:   CALIPER
Generic Device Name:   CALIPER
Proprietary Device Name:   CALIPER
Registered Establishment Name:  IMRAN BROTHERS INSTRUMENTS.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  IMRAN BROTHERS INSTRUMENTS.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  IMRAN BROTHERS INSTRUMENTS.
Classification:   PASSER, WIRE, ORTHOPEDIC
Generic Device Name:   GUIDE WIRE
Proprietary Device Name:   PRECISE INSTRUMENT
Registered Establishment Name:  JOIMAX GMBH.
Classification:   REAMER
Generic Device Name:   REAMER
Proprietary Device Name:   PRECISE INSTRUMENT; THESSYS
Registered Establishment Name:  JOIMAX GMBH.
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   PRECISE INSTRUMENT; THESSYS
Registered Establishment Name:  JOIMAX GMBH.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER
Proprietary Device Name:   KASIOS TCP
Registered Establishment Name:  KASIOS.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   BONE VOID FILLER, FILLER, BETA-TRICALCIUM PHOSPHATE
Proprietary Device Name:   CERASORB ORTHO
Registered Establishment Name:  CURASAN AG, FRANKFURT FACILITY.
Classification:   PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Generic Device Name:   SHOULDER PROSTHESIS
Proprietary Device Name:   INGEN TOTAL SHOULDER
Registered Establishment Name:  INGEN ORTHOPEDICS LLC.
Classification:   TEMPLATE
Generic Device Name:   GRAVITY ASSISTED GUIDE
Proprietary Device Name:   GRAVITY
Registered Establishment Name:  SAN-TECH SURGICAL SARL.
Classification:   TWISTER, WIRE
Generic Device Name:   GUIDEWIRE, STYLET, BRAIDED STYLET
Proprietary Device Name:   TWIST STYLET WIRE
Registered Establishment Name:  RGI MEDICAL MANUFACTURING INC..
Classification:   PROBE
Generic Device Name:   PROBES
Proprietary Device Name:   A.D. SURGICO, LTD.
Registered Establishment Name:  A.D. SURGICO, LTD..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   A.D. SURGICO, LTD.
Registered Establishment Name:  A.D. SURGICO, LTD..
Classification:   PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   ANKLE PROSTHESIS
Proprietary Device Name:   TOPEZ TOTAL ANKLE REPLACEMENT
Registered Establishment Name:  TOPEZ ORTHOPEDICS, INC.
Classification:   SCREWDRIVER
Generic Device Name:   SCREWDRIVER
Proprietary Device Name:   NONE
Registered Establishment Name:  ORTHOPRO LLC.
Classification:   GAUGE, DEPTH
Generic Device Name:   GAUGE, DEPTH
Proprietary Device Name:   NONE
Registered Establishment Name:  ORTHOPRO LLC.
Classification:   COUNTERSINK
Generic Device Name:   COUNTERSINK
Proprietary Device Name:   NONE
Registered Establishment Name:  ORTHOPRO LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   SCREW MEASURING PLATE
Proprietary Device Name:   NONE
Registered Establishment Name:  ORTHOPRO LLC.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   CANNULATED SCREW SYSTEM
Proprietary Device Name:   ORTHOPRO CANNULATED SCREW SYSTEM (C.S.S.)
Registered Establishment Name:  ORTHOPRO LLC.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  JR BROTHERS SURGICAL INSTRUMENTS.

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Last Modified: 29 April 2006
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