OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY

OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY is an FDA 510(k)-cleared medical device (K954208) manufactured by Exactech, 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 February 25, 1996. Regulation: 8.