Exactech Alteon Monobloc Revision Stem

Exactech Alteon Monobloc Revision Stem is an FDA 510(k)-cleared medical device (K181532) 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 September 3, 2018. Regulation: 8.