Coalition AGX Plate and Coalition AGX Spacer

Coalition AGX Plate and Coalition AGX Spacer is an FDA 510(k)-cleared medical device (K142218) manufactured by Globus Medical, 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 30, 2015. Regulation: 8.