510(k) Report

Devices descending from K050325

38 later devices reach Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe201332
+1K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117—
+1K100912Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator…Kirwan Surgical Products, Inc.20100—
+1K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc.200732—
+2K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe20240—
+2K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.20231—
+2K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.20160—
+2K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc.20160—
+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—
+2K111597Disposable Stimulating ElectrodeNuvasive, Inc.201110—
+2K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119—
+2K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+2K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919—
+2K073229Nerve Monitoring CablePioneer Surgical Technology20085—
+2K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe200719—
+3K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC20240—
+3K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+3K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K133348Stim ProbeSpes Medica Srl201411
+3K140088Phantom XL Insulated DilatorsTedan Surgical Innovations, LLC20142—
+3K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+3K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated20129—
+3K110712Drytouch Suction Stimulator ProbeNeurovision Medical Products, Inc.20113—
+4K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.20231—
+4K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+4K212164Mapping Suction ProbeInomed Medizintechnik GmbH20220—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K173526SENTIO MMG Gen 2Medos International SARL20182—
+4K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation20160—
+4K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+5K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…Tedan Surgical Innovations20260—
+5K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—