SMOOTH OR THREADED METALLIC BONE FASTENER

SMOOTH OR THREADED METALLIC BONE FASTENER is an FDA 510(k)-cleared medical device (K131640) manufactured by Biomedical Ent., 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 October 15, 2013. Regulation: 8.