ALPHA BIO BONE FIXATION SCREW SYSTEM

ALPHA BIO BONE FIXATION SCREW SYSTEM is an FDA 510(k)-cleared medical device (K063769) manufactured by Alpha-Bio Tec , Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2007. Regulation: 8.