PERIMETER INTERBODY FUSION DEVICE

PERIMETER INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K131669) 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 October 31, 2013. Regulation: 8.