TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM

TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM is an FDA 510(k)-cleared medical device (K141029) 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 17, 2014. Regulation: 8.