Exactech Equinoxe Stemless Shoulder

Exactech Equinoxe Stemless Shoulder is an FDA 510(k)-cleared medical device (K173388) 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 March 8, 2018. Regulation: 8.