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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:   STRIPPER, SURGICAL
Generic Device Name:   STRIPPER
Proprietary Device Name:   STRIPPER
Registered Establishment Name:  SOBYTEK INSTRUMENTS CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   ORTHOPEDIC SURGERY SCISSORS
Proprietary Device Name:   ORTHOPEDIC SURGERY SCISSORS
Registered Establishment Name:  SOBYTEK INSTRUMENTS CO..
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SOLATCH INTERNATIONAL INC.
Registered Establishment Name:  SOLATCH INTERNATIONAL INC..
Classification:   BONE MILL
Generic Device Name:   BONE MILL
Proprietary Device Name:   OSTEODISC
Registered Establishment Name:  CITAGENIX, INC..
Classification:   PASSER
Generic Device Name:   VARIOUS STERILE AND NON-STERILE SUTURE PASSERS
Proprietary Device Name:   MULTIPLE BRAND NAMES
Registered Establishment Name:  ORBIT SURGICAL EQUIPMENT LLC.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   VARIOUS STERILE AND NON-STERILE TRACTION DEVICES
Proprietary Device Name:   MULTIPLE BRAND NAMES
Registered Establishment Name:  ORBIT SURGICAL EQUIPMENT LLC.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   VERTEBRAL BODY REPLACEMENT
Proprietary Device Name:   STANSION MATRIX
Registered Establishment Name:  SPINEWORKS, LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   VARIOUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SPINEWORKS, LLC.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  RAYDENT INSTRUMENTS.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  RAYDENT INSTRUMENTS.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  RAYDENT INSTRUMENTS.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  RAYDENT INSTRUMENTS.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  DESCON TRADING COMPANY.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL US
Proprietary Device Name:   CALIPER, CLINICAL US
Registered Establishment Name:  DESCON TRADING COMPANY.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  DESCON TRADING COMPANY.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  DESCON TRADING COMPANY.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  DR SIRJ SURGICAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  DR SIRJ SURGICAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  DR SIRJ SURGICAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  DR SIRJ SURGICAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  TRISPO INDUSTRIES.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  TRISPO INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  TRISPO INDUSTRIES.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  TRISPO INDUSTRIES.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   JAMIL STAR INDUSTRIES
Registered Establishment Name:  JAMIL STAR INDUSTRIES.
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTERS
Proprietary Device Name:   WIRE CUTTING PLIERS
Registered Establishment Name:  SPECTRUM SURGICAL SUPPLIES.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   VARIOUS TYPES OF BOWLS SURGICAL USE
Proprietary Device Name:   LOTION BOWLS
Registered Establishment Name:  SPECTRUM SURGICAL SUPPLIES.
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   GONIOMETER
Proprietary Device Name:   GONIOMETER
Registered Establishment Name:  SPECTRUM SURGICAL SUPPLIES.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   FILLER,BONE VOID,CALCIUM COMPOUND
Proprietary Device Name:   FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
Registered Establishment Name:  RADIUS MEDICAL, LLC.
Classification:   PLATE, FIXATION, BONE
Generic Device Name:   BONE PLATE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOTECH INTERNATIONAL.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   BONE SCREW
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIOTECH INTERNATIONAL.
Classification:   SCISSORS, ORTHOPEDIC, SURGICAL
Generic Device Name:   SCISSORS
Proprietary Device Name:   SCISSORS
Registered Establishment Name:  TC MEDICLINE INTERNATIONAL.
Classification:   PROBE
Generic Device Name:   PROBE
Proprietary Device Name:   PROBE
Registered Establishment Name:  TC MEDICLINE INTERNATIONAL.
Classification:   RONGEUR
Generic Device Name:   RONGEUR
Proprietary Device Name:   RONGEUR
Registered Establishment Name:  TC MEDICLINE INTERNATIONAL.
Classification:   CALIPER
Generic Device Name:   CALIPER, CLINICAL USE
Proprietary Device Name:   CALIPER, CLINICAL USE
Registered Establishment Name:  TC MEDICLINE INTERNATIONAL.
Classification:   APPLIER, CERCLAGE
Generic Device Name:   CERCLAGE APPLIER
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   AWL
Generic Device Name:   AWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   BRACE, DRILL
Generic Device Name:   DRILL BRACE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   BIT, DRILL
Generic Device Name:   DRILL BITS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   TYPES OF BURRS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  BIO-BRIDGE SCIENCE, INC..

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Last Modified: 29 April 2006
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