OrthoFix FORZA® XP Expandable Spacer System. Catalog #28-3146

Vendor/Manufacturer: OrthoFix

Product/Product Line: FORZA® XP Expandable Spacer System

Vendor/Manufacturer Catalog #: 28-3146

Global Unique Device (GUD) Primary Device Identifier Number: 18257200122820

Global Unique Device (GUD) Device Description:

12.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code: MAX

FDA Classification Product Code Device Name:

Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission: K172696

The OrthoFix FORZA® XP Expandable Spacer System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Atlas Spine Expandable Interbody System

2. Centurion POCT System

3. SKYHAWK Interbody Fusion System

4. SKYHAWK Lateral Plate System

5. FORZA Spacer System

For more information, please visit us at Infonomics.com