Equinoxe® Scapula Fracture System

Equinoxe® Scapula Fracture System is an FDA 510(k)-cleared medical device (K243275) 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 June 25, 2025. Regulation: 8.