TWIST-OFF (TM) SCREW

TWIST-OFF (TM) SCREW is an FDA 510(k)-cleared medical device (K971069) manufactured by Landos, 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 8, 1997. Regulation: 8.