Xsert Lumbar Expandable Interbody System

Xsert Lumbar Expandable Interbody System is an FDA 510(k)-cleared medical device (K160959) manufactured by X-Spine Systems, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 16, 2016. Regulation: 8.