Integra TITAN Reverse Shoulder System

Integra TITAN Reverse Shoulder System is an FDA 510(k)-cleared medical device (K161189) manufactured by Integra LifeSciences Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2016. Regulation: 8.