Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System. Catalog #436013D

Vendor/Manufacturer: Medtronic

Product/Product Line: T2 Stratosphere™ Expandable Corpectomy System

Vendor/Manufacturer Catalog #: 436013D

Global Unique Device (GUD) Primary Device Identifier Number: 

00643169663145

Global Unique Device (GUD) Device Description: 

CENTERPIECE 436013D 13MM D-SIZE

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Vertebral body prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

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

2. VERTE-STACK Spinal System®

3. T2 ALTITUDE™ Expandable Corpectomy System

4. T2 XVBRTM Spinal System

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