Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid is an FDA 510(k)-cleared medical device (K183696) manufactured by Tornier, 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 January 29, 2019. Regulation: 8.