Exactech Alteon Modular Dual Mobility (MDM) System

Exactech Alteon Modular Dual Mobility (MDM) System is an FDA 510(k)-cleared medical device (K190890) 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 October 21, 2019. Regulation: 8.