Vendor/Manufacturer: Nuvasive
Product/Product Line: X-CORE® MINI Expandable Vertebral Body Replacement
Vendor/Manufacturer Catalog #: 5962427
Global Unique Device (GUD) Primary Device Identifier Number:
00887517269959
Global Unique Device (GUD) Device Description:
X-CORE Mini Core, Ø12mm 42-74mm
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, PLR
FDA Classification Product Code Device Name(s):
MQP: Spinal Vertebral Body Replacement Device
PLR: Spinal Vertebral Body Replacement Device - Cervical
The NuVasive X-CORE® MINI Expandable Vertebral Body Replacement is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
Comentarios