REVO ROTATOR CUFF REPAIR SYSTEM

REVO ROTATOR CUFF REPAIR SYSTEM is an FDA 510(k)-cleared medical device (K941691) manufactured by Linvatec Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 1994. Regulation: 8.