CONCORD Plus Radiopaque Bone Cement

CONCORD Plus Radiopaque Bone Cement is an FDA 510(k)-cleared medical device (K162618) 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 January 22, 2017. Regulation: 8.