510(k) Report

Devices descending from K163565

7 later devices reach MR8 Drill System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233958hekaDrillZethon, Ltd.20240—
+1K193630hekaDrillZethon, Ltd.20210—
+1K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+2K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+2K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—