TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws is an FDA 510(k)-cleared medical device (K182346) 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 November 25, 2018. Regulation: 8.