Medtronic VERTE-STACK® Spinal System. Catalog #XIB0303007

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: Medtronic VERTE-STACK® Spinal System

Vendor/Manufacturer Catalog #: XIB0303007

Global Unique Device (GUD) Primary Device Identifier Number: 00721902842733

Global Unique Device (GUD) Device Description:

SPACER XIB0303007 13MMX15 DEG ADD-ON CGE

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 Submission: K021791 The Medtronic VERTE-STACK® Spinal System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. VERTE-SPAN Spinal System

2. DePuy AcroMed Stackable Cage System

3. OEC/Rezaian Spinal Fixator

4. Osteotech Vertebral Body Replacement Device

5. PYRAMESH-C Implant System

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