Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: Medtronic VERTE-STACK® Spinal System
Vendor/Manufacturer Catalog #: 6240864
Global Unique Device (GUD) Primary Device Identifier Number: 00613994305183
Global Unique Device (GUD) Device Description:
IMPLANT 6240864 ANATOMIC 16 X 14 X 8MM
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 , K070173 The Medtronic VERTE-STACK® Spinal System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. VERTE-SPAN Spinal System
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