Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System. Catalog #4360160

Vendor/Manufacturer: Medtronic

Product/Product Line: T2 Stratosphere™ Expandable Corpectomy System

Vendor/Manufacturer Catalog #: 4360160

Global Unique Device (GUD) Primary Device Identifier Number:

00643169650886

Global Unique Device (GUD) Device Description:

ENDCAP 4360160 16MM 0 DEGREE

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: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code(s): MQP

FDA Classification Product Code Device Name(s):

Spinal Vertebral Body Replacement Device

FDA Premarket Submissions: K173125

The Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Aesculap HydroLift VBR