510(k) K132226

METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT by Merete Medical GmbH — Product Code HRS

K132226 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT". The FDA issued a decision of Substantially Equivalent on August 9, 2013. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Merete Medical GmbH has at least 10 other 510(k) clearances on record.