Exactech Equinoxe Humeral Augmented Trays

Exactech Equinoxe Humeral Augmented Trays is an FDA 510(k)-cleared medical device (K191561) 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 August 19, 2019. Regulation: 8.