OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00

OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 is an FDA 510(k)-cleared medical device (K132479) manufactured by Interventional Spine, 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 September 18, 2013. Regulation: 8.