510(k) Report

Devices descending from K991583

44 later devices reach Neurosign 400, 4 Channel Motor Nerve Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+1K083242Neurosign Avalanche Motor Nerve MonitorThe Magstim Company, Ltd.20094—
+1K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeTechnomed Europe200538—
+2K233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.20240—
+2K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+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—
+3K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+3K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+3K223254C2 XploreInomed Medizintechnik GmbH20230—
+3K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+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—
+3K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+3K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119—
+3K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+3K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919—
+3K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+3K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe200719—
+4K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+4K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K133348Stim ProbeSpes Medica Srl201411
+4K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+4K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+4K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+4K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc.20113—
+5K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K212164Mapping Suction ProbeInomed Medizintechnik GmbH20220—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K173526SENTIO MMG Gen 2Medos International SARL20182—
+5K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+5K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+6K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+6K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—