IRIX-A LUMBAR INTEGRATED FUSION SYSTEM

IRIX-A LUMBAR INTEGRATED FUSION SYSTEM is an FDA 510(k)-cleared medical device (K133947) 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 July 28, 2014. Regulation: 8.