510(k) Report

Devices descending from K121264

12 later devices reach Triton Electric High Torque Handpiece and Software Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+2K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+2K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+2K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+3K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+3K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+3K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+3K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—