510(k) K213454

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm by Medtronic Powered Surgical Solutions — Product Code HBE

K213454 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm". The FDA issued a decision of Substantially Equivalent on November 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. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.