IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM

IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM is an FDA 510(k)-cleared medical device (K132640) manufactured by Conformis, 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 December 4, 2013. Regulation: 8.