Exactech® Equinoxe® Reverse Shoulder Glenospheres

Exactech® Equinoxe® Reverse Shoulder Glenospheres is an FDA 510(k)-cleared medical device (K193098) 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 February 19, 2020. Regulation: 8.