MR8 Drill System, Midas Rex MR8 ClearView Tools

MR8 Drill System, Midas Rex MR8 ClearView Tools is an FDA 510(k)-cleared medical device (K183515) manufactured by Medtronic Powered Surgical Solutions. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2019. Regulation: 8.