The Small PLATEAU (PLATEAU-C) Spacer System

The Small PLATEAU (PLATEAU-C) Spacer System is an FDA 510(k)-cleared medical device (K161127) manufactured by Life 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 December 21, 2016. Regulation: 8.