Vendor/Manufacturer: EIT Emerging Implant Technologies
Product/Product Line: Cellular Titanium® Spinal Fusion Cages
NOTE: Also marketed as: DePuy Synthes CONDUITâ„¢ Interbody Platform
Vendor/Manufacturer Catalog #: CUI8070L
Global Unique Device (GUD) Primary Device Identifier Number: 04260557770665
Global Unique Device (GUD) Device Description:
EIT CIF cage, H 7mm, 8°, L
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metallic 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 metal [e.g., titanium (Ti)] 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): ODP
FDA Classification Product Code Device Name(s):
Intervertebral Fusion Device With Bone Graft, Cervical
FDA Premarket Submission(s): K170503
The EIT™ Cellular Titanium® Spinal Fusion Cage is
SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com