Irix-C Cervical Integrated Fusion System

Irix-C Cervical Integrated Fusion System is an FDA 510(k)-cleared medical device (K162944) 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 6, 2016. Regulation: 8.