MERETE 3.0 AND 3.5 MM LOCKING SCREWS

MERETE 3.0 AND 3.5 MM LOCKING SCREWS is an FDA 510(k)-cleared medical device (K081513) 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 July 17, 2008. Regulation: 8.