LEVA (TM) SPACER SYSTEM

LEVA (TM) SPACER SYSTEM is an FDA 510(k)-cleared medical device (K141980) manufactured by Spine Wave, 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 January 25, 2015. Regulation: 8.