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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:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   VARIOUS TYPES AND SIZES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   ORTHOSIS, SPINAL PEDICLE FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   NAIL, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   COUNTERSINK
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   BURR, ORTHOPEDIC
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   AWL
Registered Establishment Name:  SYNTHES GMBH.
Classification:   STARTER, BONE SCREW
Generic Device Name:   VARIOUS TYPES & SIZES OF BONE SCREW STARTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   TREPHINE
Generic Device Name:   TREPHINE, VARIOUS
Proprietary Device Name:   TREPHINE, VARIOUS
Registered Establishment Name:  SYNTHES GMBH.
Classification:   CUTTER, WIRE
Generic Device Name:   VARIOUS
Proprietary Device Name:   VARIOUS
Registered Establishment Name:  SYNTHES GMBH.
Classification:   SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Generic Device Name:   SYNEX
Proprietary Device Name:   SYNEX
Registered Establishment Name:  SYNTHES GMBH.
Classification:   FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Generic Device Name:   BUTTON PLATE
Proprietary Device Name:   SYNTHES BUTTON PLATE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Generic Device Name:   VARIOUS TYPES AND SIZES OF MULTIPLE COMPONENT METAL COMPOSITE FIXATION APPLIANCE
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   PROBE
Generic Device Name:   VARIOUS TYPES AND SIZES OF PROBES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Generic Device Name:   VARIOUS TYPES AND SIZES OF NAIL/BLADE/PLATE COMBINATION FIXATION APPLIANCES.
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Generic Device Name:   VARIOUS TYPES&SIZES OF INTRAMEDULLARY NAILS&ACCESSORIES
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   TWISTER, WIRE
Generic Device Name:   VARIOUS TYPES AND SIZES OF WIRE TWISTERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   WASHER, BOLT, NUT, NON-SPINAL, METALLIC
Generic Device Name:   VARIOUS TYPES AND SIZES OF METALLIC NON SPINAL WASHERS,BOLTS,AND NUTS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   FILLER, BONE VOID, CALCIUM COMPOUND
Generic Device Name:   VARIOUS TYPES AND SIZES OF BONE VOID FILLERS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  SYNTHES GMBH.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   POWERED ORTHOPEDIC SURGICAL INSTRUMENT
Proprietary Device Name:   EMS SWISS ORTHOCLAST
Registered Establishment Name:  E.M.S. ELECTRO MEDICAL SYSTEMS S.A..
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
Generic Device Name:   POWER SAW & ATTACHMENT
Proprietary Device Name:   SODEM POWER SYSTEM
Registered Establishment Name:  SODEM SYSTEMS.
Classification:   INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Generic Device Name:   POWER SAW & ATTACHMENT
Proprietary Device Name:   SODEM POWER SYSTEM
Registered Establishment Name:  SODEM SYSTEMS.
Classification:   BIT, DRILL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   MIXER, CEMENT, FOR CLINICAL USE
Generic Device Name:   CEMENT MIXING BOWL
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   REAMER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   DRIVER, PROSTHESIS
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PUSHER, SOCKET
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   SCREWDRIVER
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   EXTRACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   IMPACTOR
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   SCREW, FIXATION, BONE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   AWL
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.
Classification:   TEMPLATE
Generic Device Name:   VARIOUS
Proprietary Device Name:   MULTIPLE
Registered Establishment Name:  ZIMMER GMBH.

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Last Modified: 29 April 2006
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