CEMEX SYSTEM GENTA FAST BONE CEMENT

CEMEX SYSTEM GENTA FAST BONE CEMENT is an FDA 510(k)-cleared medical device (K043403) 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 December 27, 2004. Regulation: 8.