510(k) Report

Devices descending from K981315

36 later devices reach Navitrack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+2K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+2K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+2K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+4K110911Renaissance SystemMazor Robotics, Ltd.201124—
+4K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+5K182359HipCheckStryker Corp.20181—
+5K173946ADAPT for Gamma3Stryker GmbH20182—
+5K120812RenaissanceMazor Robotics, Ltd.2012211
+5K113228Renaissance SystemMazor Robotics, Ltd.201123—
+6K230045HipCheckStryker Corp.20230—
+6K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+6K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+6K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+7K202749ADAPT for Gamma3Stryker GmbH20200—
+7K163221Mazor XMazor Robotics, Ltd.201719—
+8K180307Mazor XMazor Robotics, Ltd.201817—
+8K172522Mazor XMazor Robotics, Ltd.20170—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+10K200935Mazor XMazor Robotics, Ltd.202015—
+11K203005Mazor XMazor Robotics, Ltd.2020141
+12K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+12K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+13K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+13K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+13K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+13K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+13K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+14K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+14K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+14K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+14K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+14K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+15K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+15K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—