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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:   PROBE
Generic Device Name:   TRANSESOPHAGEAL PROBE SHEATH COVER
Proprietary Device Name:   CIVCO TRANSESOPHAGEAL PROBE SHEATH ( COVER)
Registered Establishment Name:  CIVCO MEDICAL INSTRUMENTS CO., INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRULIFE, INC..
Classification:   GONIOMETER, AC-POWERED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRULIFE, INC..
Classification:   COMPONENT, CAST
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  TRULIFE, INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   BUCKS TRACTION
Registered Establishment Name:  FRANK STUBBS CO., INC..
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELTS
Registered Establishment Name:  FRANK STUBBS CO., INC..
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION ACCESSORIES
Proprietary Device Name:   KODEL KNEE SUNG
Registered Establishment Name:  FRANK STUBBS CO., INC..
Classification:   SPLINT, TRACTION
Generic Device Name:   TRACTION SPLINTS, HEAD IMMOBILIZERS
Proprietary Device Name:   DYNAMED
Registered Establishment Name:  GALLS A DIVISION OF ARAMARK.
Classification:   PROTRACTOR
Generic Device Name:   PROTRACTOR, ORTHOPAEDIC, TRACTOGRAPH
Proprietary Device Name:   UNIVERSAL
Registered Establishment Name:  ROYCE MEDICAL.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION, BELT
Proprietary Device Name:   PREMIUM, UNIVERSAL
Registered Establishment Name:  ROYCE MEDICAL.
Classification:   COMPONENT, CAST
Generic Device Name:   CAST SUSPENDER/TRACTION
Proprietary Device Name:   UNIVERSAL
Registered Establishment Name:  ROYCE MEDICAL.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS CEMENTED, OSTEOPHILIC FINISH
Generic Device Name:   TOTAL HIP STEMS
Proprietary Device Name:   KINAMED ATH-HA100 AND ATH-HA100 LONG TOTAL HIP STEMS
Registered Establishment Name:  KINAMED, INC..
Classification:   PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Generic Device Name:   TOTAL HIP STEMS
Proprietary Device Name:   OPTION HIP SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Generic Device Name:   POROUS COATED TOTAL HIP SYSTEM
Proprietary Device Name:   OPTION HIP SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   PLATE, FIXATION, BONE, NON-SPINAL, METALLIC
Generic Device Name:   TITANIUM CRANIOFACIAL BONE PLATING SYSTEM
Proprietary Device Name:   NEURO PRO RIGID FIXATION SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UHMWPE, PEGGED, UNCEMENTED, POLYMER/METAL/POLYMER
Generic Device Name:   TOTAL KNEE SYSTEM
Proprietary Device Name:   GEM KNEE SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   LONG STEM HIP SYSTEM
Proprietary Device Name:   REALITX (TM) LONG STEM HIP SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   PATELLO-FEMORAL REPLACEMENT IMPLANT
Proprietary Device Name:   KINEMATCH (TM) PATELLO-FEMORAL RESURFACING IMPLANT CEMENTED
Registered Establishment Name:  KINAMED, INC..
Classification:   CERCLAGE, FIXATION
Generic Device Name:   CERCLAGE
Proprietary Device Name:   ISO-ELASTIC CERCLAGE SYSTEM
Registered Establishment Name:  KINAMED, INC..
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   REPLACEMENT DRILL BURS
Proprietary Device Name:   MICRO-AIRE ZIMMER
Registered Establishment Name:  MICROAIRE SURGICAL INSTRUMENTS, LLC.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   POWERED WIRE DRIVER WITH VARIOUS ACCESSORIES.
Proprietary Device Name:   MICROAIRE SMARTDRIVER, 6640/664OE
Registered Establishment Name:  MICROAIRE SURGICAL INSTRUMENTS, LLC.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   POWER SOURCE, VARIOUS MODELS OF SAWS/DRILLS, AND ACCESSORIES
Proprietary Device Name:   MICROAIRE SMARTDRIVE SYSTEM, 600 SERIES
Registered Establishment Name:  MICROAIRE SURGICAL INSTRUMENTS, LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ORTHOPEDIC DRILL
Proprietary Device Name:   MICROAIRE BATTERY SMART DRIVER
Registered Establishment Name:  MICROAIRE SURGICAL INSTRUMENTS, LLC.
Classification:   ARTHROSCOPE
Generic Device Name:   VARIOUS TYPES OF ENDOSCOPIC RELEASE
Proprietary Device Name:   MICROAIRE ENDOSCOPIC RELEASE SYSTEM
Registered Establishment Name:  MICROAIRE SURGICAL INSTRUMENTS, LLC.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   INSERTION DEVICE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   BELT, PELVIC, TRACTION
Generic Device Name:   PELVIC TRACTION BELT
Proprietary Device Name:   PELVIC TRACTION BELT
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   COMPONENT, CAST
Generic Device Name:   CAST COMPONENT
Proprietary Device Name:   CAST COMPONENT
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   COMPONENT, TRACTION, NON-INVASIVE
Generic Device Name:   BUCKS TRACTION
Proprietary Device Name:   BUCKS TRACTION
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   APPARATUS, TRACTION, NON-POWERED
Generic Device Name:   TRACTION APPARATUS AND ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  DJ ORTHOPEDICS, LLC.
Classification:   ARTHROMETER
Generic Device Name:   KNEE LIGAMENT TEST SYSTEM
Proprietary Device Name:   KT1000/S KNEE LIGAMENT ARTHROMETER
Registered Establishment Name:  MEDMETRIC CORP..
Classification:   DYNAMOMETER, NONPOWERED
Generic Device Name:   DEVICE, MEASURING, FORCE/DISPLACEMENT, PATELLA FEMORAL JOINT
Proprietary Device Name:   PATELLA PUSHER
Registered Establishment Name:  MEDMETRIC CORP..
Classification:   GONIOMETER, NONPOWERED
Generic Device Name:   KNEE LIGAMENT TEST INSTRUMENT
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  MEDMETRIC CORP..
Classification:   ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic Device Name:   ANTI-SHOCK TROUSERS
Registered Establishment Name:  VINYL TECHNOLOGY, INC..
Classification:   RONGEUR
Generic Device Name:   DISC RONGUER
Proprietary Device Name:   ORTHOPEDIC RONGEUR
Registered Establishment Name:  KOROS USA, INC..
Classification:   CUTTER, WIRE
Generic Device Name:   WIRE CUTTER
Proprietary Device Name:   WIRE CUTTER
Registered Establishment Name:  KOROS USA, INC..
Classification:   WASHER, BOLT NUT
Generic Device Name:   316L WASHER
Proprietary Device Name:   MARKER RING
Registered Establishment Name:  KOROS USA, INC..
Classification:   WIRE, SURGICAL
Generic Device Name:   STERNATOMY SUTURE
Proprietary Device Name:   WIRE, SURGICAL
Registered Establishment Name:  KOROS USA, INC..
Classification:   ARTHROSCOPE
Generic Device Name:   SPINAL ENDOSCOPE
Proprietary Device Name:   NEUROVIEW ENDOSCOPE
Registered Establishment Name:  INTEGRA NEURO SCIENCES.
Classification:   DISPENSER, CEMENT
Generic Device Name:   DISPENSER, CEMENT
Proprietary Device Name:   OSTEOJECT BONE CEMENT DELIVERY SYSTEM
Registered Establishment Name:  INTEGRA NEURO SCIENCES.

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Last Modified: 29 April 2006
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