XCage™ Interbody Fusion System

XCage™ Interbody Fusion System is an FDA 510(k)-cleared medical device (K160076) manufactured by Ouroboros Medical, 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 October 12, 2016. Regulation: 8.