510(k) K191049

Stryker MIS and Footed Attachments by Stryker Corporation — Product Code HBE

K191049 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker MIS and Footed Attachments". The FDA issued a decision of Substantially Equivalent on June 18, 2019. 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.