Zavation receives US FDA approval to market Normandy VBR System

Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, has received 510(k) clearance from the FDA to market Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage). 

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.