EPICAGE INTERBODY FUSION DEVICE

EPICAGE INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K130548) manufactured by Alphatec 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 April 17, 2013. Regulation: 8.