510(k) Report

Devices descending from K010019

54 later devices reach Sterile Subdermal Needle Electrodes through their predicates, nearest generation first.

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