510(k) Report

Devices descending from K980148

498 later devices reach Neurosign 800, 8 Channel Motor Nerve Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+1K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeTechnomed Europe200538—
+1K030526Pediguard Nerve Detector SystemSpine Vision, Inc.20046—
+1K992869Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc.1999484—
+2K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…Medtronic Xomed, Inc.20221—
+2K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+2K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…Spineguard S.A.20154—
+2K123390Pediguard Nerve Detector SystemSpineguard S.A.20135—
+2K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+2K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117—
+2K100912Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator…Kirwan Surgical Products, Inc.20100—
+2K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc.200732—
+2K063305Stimulating Bur GuardMedtronic Xomed, Inc.2006424—
+2K031003Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc.2003351
+2K014165Stimulus - Dissection InstrumentsMedtronic Xomed, Inc.200265—
+3K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+3K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+3K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)Medtronic Xomed, Inc.20230—
+3K223254C2 XploreInomed Medizintechnik GmbH20230—
+3K201454DSG Connect TechnologySpineguard S.A.20211—
+3K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181—
+3K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+3K152747DSG Threaded Drill SystemSpineguard S.A.20163—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+3K133348Stim ProbeSpes Medica Srl201411
+3K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC20143—
+3K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+3K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122—
+3K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+3K111671Seaspine Monopolar Probe SysyemSeaspine, Inc.20110—
+3K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+3K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+3K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119—
+3K110422Surgical StimulatorsTechnomed Europe201121
+3K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+3K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919—
+3K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+3K072736Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC200881
+3K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe200719—
+3K031510Nim-SpineMedtronic Xomed200340—
+4K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+4K222106Waypoint GPSWaypoint Orthopedics, Inc.20230—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+4K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,20190—
+4K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+4K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.20172—
+4K161893Neuromonitoring KitSI-BONE, Inc.20160—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+4K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+4K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+4K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+4K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+4K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+4K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc.20113—
+4K083124NIM 3.0Medtronic Xomed, Inc.2009303
+4K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc.20082—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+5K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—