Vendor/Manufacturer: DePuy Synthes
Product/Product Line: SYNFIX® EVOLUTION Interbody Fusion
Vendor/Manufacturer Catalog #: 08.815.223S
Global Unique Device (GUD) Primary Device Identifier Number:
10705034815404
Global Unique Device (GUD) Device Description:
SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/14°-STERILE
Category 1: Spine
Category 2: Interbody Fusion Devices
Category 3: Lumbar/T-Lumbar
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Polymeric spinal interbody fusion cage
Global Medical Device Nomenclature (GMDN) Definition:
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Intervertebral body fusion device
FDA Classification Product Code(s): OVD
FDA Classification Product Code Device Name:
Intervertebral fusion device with integrated fixation, lumbar
The DePuy Synthes SYNFIX® EVOLUTION Interbody Fusion Device is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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