510(k) Report

Devices descending from K960714

71 later devices reach Isg Viewing Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981—
+1K964229Regulus NavigatorCompass Intl., Inc.199766—
+1K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB19990—
+2K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+2K981315NavitrackOrthosoft, Inc.199836—
+3K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+3K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+3K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+3K162176Fiagon Navigation SystemFiagon GmbH20164—
+3K161701CARTO ENT SystemBiosense Webster20163—
+3K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+3K150473FlexPointer 1.5 mmFiagon GmbH20152—
+3K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+4K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193453TruDi ProbeAcclarent, Inc.20200—
+4K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K192397TruDi Navigation SystemBiosense Webster202011
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+4K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+4K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+4K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+4K160369GuideWireFiagon GmbH20163—
+4K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+4K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+4K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+5K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+5K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+6K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K110911Renaissance SystemMazor Robotics, Ltd.201124—
+6K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+7K182359HipCheckStryker Corp.20181—
+7K173946ADAPT for Gamma3Stryker GmbH20182—
+7K120812RenaissanceMazor Robotics, Ltd.2012211
+7K113228Renaissance SystemMazor Robotics, Ltd.201123—
+8K230045HipCheckStryker Corp.20230—
+8K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+8K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+8K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+9K202749ADAPT for Gamma3Stryker GmbH20200—
+9K163221Mazor XMazor Robotics, Ltd.201719—
+10K180307Mazor XMazor Robotics, Ltd.201817—
+10K172522Mazor XMazor Robotics, Ltd.20170—
+11K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+12K200935Mazor XMazor Robotics, Ltd.202015—
+13K203005Mazor XMazor Robotics, Ltd.2020141
+14K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+14K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+15K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+15K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+15K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+15K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+15K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+16K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+16K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+16K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+16K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+16K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+17K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+17K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—