510(k) Report

Devices descending from K842956

481 later devices reach Nicolet Viking through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031510Nim-SpineMedtronic Xomed200340—
+1K971819Epoch 2000 Neurological WorkstationAxon Systems, Inc.1997464—
+2K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181—
+2K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+2K083124NIM 3.0Medtronic Xomed, Inc.2009303
+2K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc.20082—
+2K022785Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationAxon Systems, Inc.2002463—
+3K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+3K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,20190—
+3K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+3K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+3K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+3K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+3K092729Baxano Neuro Check DeviceBaxano, Inc.20091—
+3K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc.2003462—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+4K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K173526SENTIO MMG Gen 2Medos International SARL20182—
+4K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+4K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+4K072343Neurovision JJB SystemNuvasive, Inc.20070—
+4K050798Eclipse Neurological WorkstationAxon Systems, Inc.2005460—
+5K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+5K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K223254C2 XploreInomed Medizintechnik GmbH20230—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K110410MS-120BK Electric Stimulator (Extension Unit)Nihon Kohden Corp.201113—
+5K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc.2006426—
+5K061113OrthomonAxon Systems, Inc.2006450—
+6K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K151354Cervello STIMBlackrock Neuromed20162—
+6K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+6K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+6K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K210637CD Horizon™ Spinal SystemMedtronic202134—
+7K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+7K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+7K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+7K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+7K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+7K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+7K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+7K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+8K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+8K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—
+8K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+8K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—