AEQUALIS FLEX REVIVE Shoulder System

AEQUALIS FLEX REVIVE Shoulder System is an FDA 510(k)-cleared medical device (K191318) 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 June 13, 2019. Regulation: 8.