PERIMETER Interbody Fusion Device

PERIMETER Interbody Fusion Device is an FDA 510(k)-cleared medical device (K160418) manufactured by Medtronic Sofamor Danek USA, 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 6, 2016. Regulation: 8.