510(k) Report

Devices descending from K890495

69 later devices reach Nicolet Viking II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112052Carefusion Nicolet EdxCarefusion 209, Inc.201230—
+1K070608Smartep, Model M010000Intelligent Hearing Systems200716—
+1K031510Nim-SpineMedtronic Xomed200340—
+1K022719Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston20024—
+1K963662Galileo Evoked PotentialreBiosound, Inc.19970—
+2K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181—
+2K171781eVox SystemEvoke Neuroscience, Inc.20176—
+2K163326SmartEPIntelligent Hearing Systems20171—
+2K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.201712—
+2K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+2K123902Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC20130—
+2K123843Neuroepg SystemStrohl Medical Technologies201312—
+2K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+2K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+2K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.20090—
+2K083124NIM 3.0Medtronic Xomed, Inc.2009303
+2K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc.20082—
+2K031995Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc.20042—
+3K253301BraiN20® (BraiN20)Time IS Brain, S.L.20260—
+3K243982Nicolet EDXNatus Neurology Incorporated20250—
+3K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+3K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+3K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+3K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+3K193033GSI Audera ProGrason Stadler20200—
+3K192753NeuralScan SystemMedeia, Inc.20203—
+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—
+3K172743Natus VikingQuestNatus Neurology Incorporated20170—
+3K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+3K132616EPADSafeop Surgical, Inc.201411—
+3K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+3K113074Cmap ProMedical Technologies, Inc.20121—
+3K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+3K092729Baxano Neuro Check DeviceBaxano, Inc.20091—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K253767UB ERP SystemUniversal Brain20260—
+4K221959Q21Neurofield, Inc.20230—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+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—
+4K173510BioStamp nPointMc10, Inc.20180—
+4K173526SENTIO MMG Gen 2Medos International SARL20182—
+4K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+4K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+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—
+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
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—