Vendor/Manufacturer: Medtronic Sofamor Danek USA, Inc.
Product/Product Line: Anteralign™ Spinal System with Titan nanoLOCK™
Vendor/Manufacturer Catalog #: 46261250
Global Unique Device (GUD) Primary Device Identifier Number: 00763000128531
Global Unique Device (GUD) Device Description:
NANO SPACER 46261250 T 6DG 20W 12 X 9.9 X 50
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:
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
FDA Classification Product Code(s): MAX, OVD
FDA Classification Product Code Device Name(s):
MAX: Intervertebral fusion device with bone graft, lumbar
OVD: Intervertebral fusion device with integrated fixation, lumbar
The Medtronic Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology is SUBSTANTIALLY EQUIVALENT to the following products:
12. Crescent PEEK
For more information, please visit us at Infonomics.com
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