510(k) Report

Devices descending from K014165

65 later devices reach Stimulus - Dissection Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111671Seaspine Monopolar Probe SysyemSeaspine, Inc.20110—
+1K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117—
+1K031510Nim-SpineMedtronic Xomed200340—
+1K031003Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc.2003351
+2K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+2K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,20181—
+2K133348Stim ProbeSpes Medica Srl201411
+2K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC20143—
+2K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC)20145—
+2K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122—
+2K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+2K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+2K110422Surgical StimulatorsTechnomed Europe201121
+2K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+2K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919—
+2K083124NIM 3.0Medtronic Xomed, Inc.2009303
+2K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc.20082—
+2K072736Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC200881
+3K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+3K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.20200Class I
+3K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+3K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,20190—
+3K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+3K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.201811
+3K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+3K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K161893Neuromonitoring KitSI-BONE, Inc.20160—
+3K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+3K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+3K111647C2 Nervemonitor System with AccessoriesInomed Medizintechnik GmbH20112—
+3K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119—
+3K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc.20113—
+3K092729Baxano Neuro Check DeviceBaxano, Inc.20091—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+4K212164Mapping Suction ProbeInomed Medizintechnik GmbH20220—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.20210—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K173526SENTIO MMG Gen 2Medos International SARL20182—
+4K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH201612
+4K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+4K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+5K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+5K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K223254C2 XploreInomed Medizintechnik GmbH20230—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+6K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—