Globus Medical FORTIFY® Expandable Corpectomy Device. Catalog #151.905

Vendor/Manufacturer: Globus Medical

Product/Product Line: FORTIFY® Expandable Corpectomy Device

Vendor/Manufacturer Catalog #: 151.905

Global Unique Device (GUD) Primary Device Identifier Number: 

00889095046106

Global Unique Device (GUD) Device Description: 

FORTIFY 16mm Upper Endplate, 18x30mm Footprint, 12deg

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: MQP

FDA Classification Product Code Device Name: 

Spinal Vertebral Body Replacement Device

FDA Premarket Submissions: K173982 , K112756 , K121107

The Globus Medical FORTIFY® Expandable Corpectomy Device is

SUBSTANTIALLY EQUIVALENT to the following product(s): 

1. XPAND® Corpectomy Spacer

2. INDEPENDENCE MIS AGX

3. Synthes SynMesh®

4. MR Compatibility

5. PEEK Vendor

6. XPAND® Radiolucent Corpectomy Spacers

7. Stryker Spine VLIFT® Vertebral Body Replacement System

8. Ulrich ADDplus

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