IRIX-A Lumbar Integrated Fusion System

IRIX-A Lumbar Integrated Fusion System is an FDA 510(k)-cleared medical device (K171567) 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 August 27, 2017. Regulation: 8.