NuVasive X-CORE® MINI Expandable Vertebral Body Replacement. Catalog #5960011

Vendor/Manufacturer: Nuvasive

Product/Product Line: X-CORE® MINI Expandable Vertebral Body Replacement

Vendor/Manufacturer Catalog #: 5960011

Global Unique Device (GUD) Primary Device Identifier Number:

00887517267740

Global Unique Device (GUD) Device Description:

X-CORE Mini Lock Screw, Endcap

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

2. DePuy Surgical Titanium Mesh System

3. Osteotech VBR Vertebral Body Replacement

4. NuVasive Mesh System

5. NuVasive Expandable Lumbar Interbody System

6. NuVasive Adjustable Vertebral Body Replacement System

7. NuVasive® X-Core® Expandable VBR System

8. NuVasive® CoRoent® System

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