ALTEON 6.5MM BONE SCREWS

ALTEON 6.5MM BONE SCREWS is an FDA 510(k)-cleared medical device (K141797) 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 July 28, 2014. Regulation: 8.