510(k) Report

Devices descending from K932059

57 later devices reach Needle Electrodes and Disposable Scalp Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981004Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd.199856—
+2K990015Electrode NeedlesTechnomed Europe199955—
+3K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…Technomed Europe20260—
+3K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+3K050194Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc.200513—
+3K040639Isurg Disposable Subdermal Needle ElectrodeIsurgical20040—
+3K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC200250—
+4K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+4K200984Guardian Needle ElectrodeRhythmlink International, LLC20200—
+4K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl20190—
+4K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+4K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+4K140200E-Shield Multi-Paired Subdermal Needle ElectrodesNeuroinvent, Inc.20141—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+4K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+4K103103Presson ElectrodePersyst Development Corp.20112—
+4K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S.20101—
+4K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+4K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd.20085—
+5K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.20230—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K142470E-Shield Multi-paried Subdermal Needle ElectrodesNeuroinvent, Inc.20140—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K130220MR Conditional Presson ElectrodeRhythmlink International, LLC20131—
+5K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K190801PressOn Electrode HeadsetRhythmlink International, LLC20190—
+6K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+6K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+9K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+10K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+10K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+11K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+11K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+11K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+11K173526SENTIO MMG Gen 2Medos International SARL20182—
+12K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+12K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+12K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+13K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+13K230989Rod Registration FrameNu Vasive, Incorporated20230—