TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas is an FDA 510(k)-cleared medical device (K223252) 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 July 16, 2023. Regulation: 8.