Vendor/Manufacturer: Nuvasive
Product/Product Line: X-CORE® Expandable Vertebral Body Replacement
Vendor/Manufacturer Catalog #: 6591026
Global Unique Device (GUD) Primary Device Identifier Number:
00887517330734
Global Unique Device (GUD) Device Description:
X-CORE Core, Ø22mm 41-65mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Vertebral body prosthesis, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.
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
The NuVasive X-CORE® Expandable Vertebral Body Replacement is SUBSTANTIALLY EQUIVALENT to the following product(s):
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