510(k) Report

Devices descending from K991772

51 later devices reach Cutaneous (Disc) Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061148Rhythmlink Disc ElectrodesRhythmlink International, LLC200650—
+2K170138NeuronauteBioserenity20170—
+2K130287MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC20135—
+2K123915DE48-PlusGrass Technologies, an Astro-Med, Inc. Product Gro20130—
+2K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+2K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+2K072016Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…Technomed Europe20076—
+3K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.20260—
+3K254183MR Conditional Cup ElectrodesTechnomed Europe20260—
+3K192564Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc.20201—
+3K190416Dome ElectrodeCoapt, LLC201911
+3K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions20170—
+3K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC20173—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K242346Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited20242—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K223605ControlSeal Electrode (ELSB)Coapt202201
+4K213884Disposable EEG cableShenzhen Changke Connect Electronics Co., Ltd.20220—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+5K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…Ambu A/S20260—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+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
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+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—