510(k) K223199

2.1 x 255mm Drill, 22mm Stop by Biomet Microfixation — Product Code HBE

K223199 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "2.1 x 255mm Drill, 22mm Stop". The FDA issued a decision of Substantially Equivalent on November 15, 2022. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Biomet Microfixation has at least 10 other 510(k) clearances on record.