TENDON WRAP TENDON PROTECTOR

TENDON WRAP TENDON PROTECTOR is an FDA 510(k)-cleared medical device (K053655) manufactured by Integra LifeSciences Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2006. Regulation: 8.