Equinoxe® Central Screw Baseplate System

Equinoxe® Central Screw Baseplate System is an FDA 510(k)-cleared medical device (K233482) 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 July 17, 2024. Regulation: 8.