510(k) K191479

Velocity Alpha Highspeed Surgical Drill System by Adeor Medical AG — Product Code HBE

K191479 is an FDA 510(k) premarket notification submitted by Adeor Medical AG for the device "Velocity Alpha Highspeed Surgical Drill System". The FDA issued a decision of Substantially Equivalent on April 11, 2021. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Adeor Medical AG has at least 3 other 510(k) clearances on record.