Vendor/Manufacturer: CarboFix
Product/Product Line: CarboFix CarboClear® Lumbar Cage System
Vendor/Manufacturer Catalog #: CCLC2308
Global Unique Device (GUD) Primary Device Identifier Number: 07290110206505
Global Unique Device (GUD) Device Description:
lumbar intervertebral body fusion device
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metal-polymer composite 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 a non-bioabsorbable synthetic polymer with a metallic coating 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: MAX
FDA Classification Product Code Device Name:
Intervertebral fusion device with bone graft, lumbar
FDA Premarket Submission: K193378
The CarboFix CarboClear® Lumbar Cage System is
SUBSTANTIALLY EQUIVALENT to the following products:
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