CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL is an FDA 510(k)-cleared medical device (K021715) 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 June 11, 2002. Regulation: 8.