510(k) K213208

Twist Drills by Biomet Microfixation — Product Code HBE

K213208 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Twist Drills". The FDA issued a decision of Substantially Equivalent on December 23, 2021. 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.