Medtronic VERTE-STACK® Spinal System. Catalog #6278744

Vendor/Manufacturer: Medtronic Sofamor Danek

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

Vendor/Manufacturer Catalog #: 6278744

Global Unique Device (GUD) Primary Device Identifier Number: 00721902807572

Global Unique Device (GUD) Device Description:

SPACER 6278744 CRNS PSR 7 X 14 X 14MM

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 Submission: K021791 , K030736 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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