510(k) Report

Devices descending from K961013

60 later devices reach Disposable Needle Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112034Teca Elite Disposable Concentric NeedlesCarefusion 209, Inc.20115—
+1K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl20092—
+1K071186Modification to: Ambu Neuroline Concentric Needle ElectrodeAmbu A/S20073—
+1K990015Electrode NeedlesTechnomed Europe199955—
+2K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…Technomed Europe20260—
+2K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…Natus Manufacturing Limited20150—
+2K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+2K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+2K050194Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc.200513—
+2K040639Isurg Disposable Subdermal Needle ElectrodeIsurgical20040—
+2K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC200250—
+3K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+3K200984Guardian Needle ElectrodeRhythmlink International, LLC20200—
+3K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl20190—
+3K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+3K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+3K140200E-Shield Multi-Paired Subdermal Needle ElectrodesNeuroinvent, Inc.20141—
+3K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+3K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+3K103103Presson ElectrodePersyst Development Corp.20112—
+3K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+3K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd.20085—
+4K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.20230—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K142470E-Shield Multi-paried Subdermal Needle ElectrodesNeuroinvent, Inc.20140—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K130220MR Conditional Presson ElectrodeRhythmlink International, LLC20131—
+4K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K190801PressOn Electrode HeadsetRhythmlink International, LLC20190—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+6K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+8K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+9K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+9K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+10K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+10K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+10K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+10K173526SENTIO MMG Gen 2Medos International SARL20182—
+11K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+11K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+12K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—