MERETE DUOTHREADTM BONE SCREW

MERETE DUOTHREADTM BONE SCREW is an FDA 510(k)-cleared medical device (K050924) manufactured by Merete Medical GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 2005. Regulation: 8.