Exactech Equinoxe Small Reverse Shoulder System

Exactech Equinoxe Small Reverse Shoulder System is an FDA 510(k)-cleared medical device (K180632) 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 24, 2018. Regulation: 8.