INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM is an FDA 510(k)-cleared medical device (K132250) 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 March 23, 2014. Regulation: 8.