NuVasive X-CORE® MINI Expandable Vertebral Body Replacement. Catalog #5962427

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

FDA Premarket Submissions: K090176 , K142205 , K151651

The NuVasive X-CORE® MINI Expandable Vertebral Body Replacement is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Synthes Spine Synex Spacer System