Leva(TM) Spacer System

Leva(TM) Spacer System is an FDA 510(k)-cleared medical device (K150285) 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 March 4, 2015. Regulation: 8.