510(k) Report

Devices descending from K944612

83 later devices reach Acustar I Advanced Surgical Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071063LinasysPathfinder Therapeutics, Inc.200710—
+1K960714Isg Viewing WandI.S.G. Technologies, Inc.199671—
+2K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+2K093494Linasys Image-Guided Liver Surgery SystemPathfinder Therapeutics, Inc.20102—
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981—
+2K964229Regulus NavigatorCompass Intl., Inc.199766—
+2K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973—
+3K143024CAS-One LiverCascination AG20150—
+3K133573Fiagon Navigation SystemFiagon GmbH201428—
+3K121479AIMInneroptic Technology, Inc.20125—
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB19990—
+3K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+3K981315NavitrackOrthosoft, Inc.199836—
+4K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+4K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+4K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+4K162176Fiagon Navigation SystemFiagon GmbH20164—
+4K161701CARTO ENT SystemBiosense Webster20163—
+4K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+4K150473FlexPointer 1.5 mmFiagon GmbH20152—
+4K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+4K141806Clear Guide OneClear Guide Medical20142—
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+5K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+5K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K201174TruDi CuretteAcclarent, Inc.20200—
+5K193453TruDi ProbeAcclarent, Inc.20200—
+5K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K192397TruDi Navigation SystemBiosense Webster202011
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+5K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+5K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+5K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+5K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+5K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+5K160369GuideWireFiagon GmbH20163—
+5K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+5K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+5K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+6K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+6K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+6K190532TruDi NAV WireAcclarent, Inc.20190—
+6K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+6K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+6K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+7K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+7K110911Renaissance SystemMazor Robotics, Ltd.201124—
+7K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+8K182359HipCheckStryker Corp.20181—
+8K173946ADAPT for Gamma3Stryker GmbH20182—
+8K120812RenaissanceMazor Robotics, Ltd.2012211
+8K113228Renaissance SystemMazor Robotics, Ltd.201123—
+9K230045HipCheckStryker Corp.20230—
+9K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+9K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+9K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+10K202749ADAPT for Gamma3Stryker GmbH20200—
+10K163221Mazor XMazor Robotics, Ltd.201719—
+11K180307Mazor XMazor Robotics, Ltd.201817—
+11K172522Mazor XMazor Robotics, Ltd.20170—
+12K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+13K200935Mazor XMazor Robotics, Ltd.202015—
+14K203005Mazor XMazor Robotics, Ltd.2020141
+15K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+15K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+16K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+16K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+16K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+16K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+16K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+17K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+17K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+17K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+17K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+17K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+18K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+18K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—