510(k) Report

Devices descending from K230064

3 later devices reach Mazor X System (Mazor X Stealth Edition) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+1K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+2K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—