Aequalis PerFORM+ Shoulder System

Aequalis PerFORM+ Shoulder System is an FDA 510(k)-cleared medical device (K150583) 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 April 22, 2015. Regulation: 8.