Medtronic Anteralign™ Spinal System with Titan nanoLOCK™. Catalog #46261250

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

FDA Premarket Submission(s): K212524 , K214010

The Medtronic Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology is SUBSTANTIALLY EQUIVALENT to the following products:

1. Endoskeleton™ TL Hyperlordotic Interbody System