510(k) Report

Devices descending from K073467

32 later devices reach Spineassist System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K110911Renaissance SystemMazor Robotics, Ltd.201124—
+2K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K182359HipCheckStryker Corp.20181—
+3K173946ADAPT for Gamma3Stryker GmbH20182—
+3K120812RenaissanceMazor Robotics, Ltd.2012211
+3K113228Renaissance SystemMazor Robotics, Ltd.201123—
+4K230045HipCheckStryker Corp.20230—
+4K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+4K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+4K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+5K202749ADAPT for Gamma3Stryker GmbH20200—
+5K163221Mazor XMazor Robotics, Ltd.201719—
+6K180307Mazor XMazor Robotics, Ltd.201817—
+6K172522Mazor XMazor Robotics, Ltd.20170—
+7K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+8K200935Mazor XMazor Robotics, Ltd.202015—
+9K203005Mazor XMazor Robotics, Ltd.2020141
+10K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+10K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+11K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+11K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+11K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+12K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+12K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+12K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+12K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+12K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+13K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+13K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—