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Medtronic Powered Surgical Solutions

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories4
Latest FDA decision2021-11-23
TypeNumberDevice NameCodeDateActions
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 7.5mmHBE2021-11-23 View
510(k) K183644 Stealth-Midas MR8 SystemOLO2019-05-22 View
510(k) K183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsHBC2019-05-12 View
510(k) K170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting toolsHBC2017-05-15 View
510(k) K163565 MR8 Drill SystemHBC2017-03-28 View
510(k) K163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesHBB2017-03-23 View
510(k) K160713 Stealth-Midas SystemOLO2016-05-26 View