510(k) Report

Devices descending from K140167

21 later devices reach Renaissance X System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+2K163221Mazor XMazor Robotics, Ltd.201719—
+3K180307Mazor XMazor Robotics, Ltd.201817—
+3K172522Mazor XMazor Robotics, Ltd.20170—
+4K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+5K200935Mazor XMazor Robotics, Ltd.202015—
+6K203005Mazor XMazor Robotics, Ltd.2020141
+7K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—