Exactech® Alteon® HA Femoral Stem

Exactech® Alteon® HA Femoral Stem is an FDA 510(k)-cleared medical device (K162732) 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 April 25, 2017. Regulation: 8.