Equinoxe Mega Prosthesis

Equinoxe Mega Prosthesis is an FDA 510(k)-cleared medical device (K143659) 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 8, 2015. Regulation: 8.