510(k) K081513

MERETE 3.0 AND 3.5 MM LOCKING SCREWS by Merete Medical GmbH — Product Code HWC

K081513 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "MERETE 3.0 AND 3.5 MM LOCKING SCREWS". The FDA issued a decision of Substantially Equivalent on July 18, 2008. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Merete Medical GmbH has at least 10 other 510(k) clearances on record.