510(k) K243491

SternalPlate Expansion by Stryker Leibinger GmbH & Co KG — Product Code HRS

K243491 is an FDA 510(k) premarket notification submitted by Stryker Leibinger GmbH & Co KG for the device "SternalPlate Expansion". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker Leibinger GmbH & Co KG has at least 10 other 510(k) clearances on record.