510(k) K210377

Stryker iBur hubs and cutting accessories by Stryker Corporation — Product Code HBE

K210377 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker iBur hubs and cutting accessories". The FDA issued a decision of Substantially Equivalent on June 30, 2021. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Stryker Corporation has at least 10 other 510(k) clearances on record.