510(k) Report

Devices descending from K102130

31 later devices reach Tenzing System through their predicates, nearest generation first.

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