Exactech® Equinoxe® Stemless Humeral Components

Exactech® Equinoxe® Stemless Humeral Components is an FDA 510(k)-cleared medical device (K192097) 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 April 28, 2020. Regulation: 8.