510(k) Report

Devices descending from K182077

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200935Mazor XMazor Robotics, Ltd.202015—
+2K203005Mazor XMazor Robotics, Ltd.2020141
+3K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+4K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—