Exactech® Alteon® Short Tapered Wedge

Exactech® Alteon® Short Tapered Wedge is an FDA 510(k)-cleared medical device (K221323) 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 May 18, 2023. Regulation: 8.