DEROYAL SPINE SPACER SYSTEM

DEROYAL SPINE SPACER SYSTEM is an FDA 510(k)-cleared medical device (K131292) manufactured by Deroyal Industries, 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 February 2, 2014. Regulation: 8.