FDA grants Eden Spine 510(K) clearance for its new vertebral body replacement


The US Food and Drug Administration has granted 510(K) clearance to Eden Spine for its new generation corpectomy device, the Giza.

The Giza is an expandable titanium vertebral body replacement, with rotatable endplates, that provide multiple angulation options by simple endplates rotation. It is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture.

“What we did with the Giza is to create an intuitive spinal system designed to help the surgeon easily implant the device, swiftly adapting its height and its angulation to the patient’s characteristics, hence maximising the chances of a positive clinical outcome.” said Mourad Ben Mokhtar, head of Eden Spine’s R&D efforts.

“The approval of the Giza by the FDA is another milestone in the company’s life cycle. The Giza is patented, trademarked, CE marked, and FDA approved. It enhances the company’s technological footprint and ideally positions Eden Spine for long-term growth,” said Guillaume Viallaneix, CEO, Eden Spine.