510(k) Report

Devices descending from K061148

50 later devices reach Rhythmlink Disc Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170138NeuronauteBioserenity20170—
+1K130287MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC20135—
+1K123915DE48-PlusGrass Technologies, an Astro-Med, Inc. Product Gro20130—
+1K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+1K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+1K072016Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…Technomed Europe20076—
+2K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.20260—
+2K254183MR Conditional Cup ElectrodesTechnomed Europe20260—
+2K192564Disposable Gold Cup EEG ElectrodesDymedix Diagnostics, Inc.20201—
+2K190416Dome ElectrodeCoapt, LLC201911
+2K171102Ives MR Conditional Cup ElectrodeIves Egg Solutions20170—
+2K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC20173—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+2K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+2K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K242346Grass® MR Conditional/CT Cup ElectrodesNatus Manufacturing Limited20242—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K223605ControlSeal Electrode (ELSB)Coapt202201
+3K213884Disposable EEG cableShenzhen Changke Connect Electronics Co., Ltd.20220—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+3K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+4K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…Ambu A/S20260—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+5K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+5K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+6K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+7K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+7K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+8K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+8K173526SENTIO MMG Gen 2Medos International SARL20182—
+9K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+9K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—