Exactech® Novation® Element Press-fit Femoral Stem

Exactech® Novation® Element Press-fit Femoral Stem is an FDA 510(k)-cleared medical device (K153649) manufactured by Exactech, 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 August 30, 2016. Regulation: 8.