Axis Spine Gains FDA Clearance for Axis-ALIF

By Julie A. Vetalice

Axis Spine Gains FDA Clearance for Axis-ALIF

Axis Spine Technologies received FDA 510(k) clearance to market the Axis-ALIF, their first implant system.

Axis has developed a platform technology of build in situ modular cages as an alternative to conventional cage designs. Modular endplates are inserted in a closed position, atraumatically helping to preserve the structural integrity of the vertebral endplate.

Once in situ, the appropriate modular core is inserted and locked. Multiple combinations of endplates and cores offer numerous sagittal as well as coronal correction capabilities.

Jon Arcos, CEO & Founder, said, “We are really pleased and grateful to have received such timely clearance from FDA given the current situation. We now have the opportunity to bring this technology and its benefits to American patients ahead of plan. The next few months will be a very exciting time for the company.”

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory