510(k) K231208

Stryker Resorbable Fixation System by Stryker Leibinger GmbH & Co KG — Product Code HBW

K231208 is an FDA 510(k) premarket notification submitted by Stryker Leibinger GmbH & Co KG for the device "Stryker Resorbable Fixation System". The FDA issued a decision of Substantially Equivalent on August 14, 2023. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Stryker Leibinger GmbH & Co KG has at least 10 other 510(k) clearances on record.