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PDQ — Neurosurgical Nerve Locator Class II

FDA Device Classification

Classification Details

Product Code
PDQ
Device Class
Class II
Regulation Number
874.1820
Submission Type
Review Panel
NE
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243636neuralytixNeuralytix iD3 System (NTX-9001)June 26, 2025
K223438medos international sarlTELIGEN System Peripheral Motor Nerve Stimulation IndicationsFebruary 10, 2023
K221821alphatec spineATEC IOM Accessory InstrumentsSeptember 23, 2022
K220160spineguardPediGuard ThreadedMarch 31, 2022
K203684magstim companyNeurosign V4 Intraoperative Nerve MonitorMarch 17, 2021
K201454spineguardDSG Connect TechnologyFebruary 10, 2021
K191723alphatec spineATEC IOM Accessory InstrumentsOctober 18, 2019
K190163surgentecALARA Neuro Access KitJuly 16, 2019
K182617alphatec spineATEC IOM Accessory InstrumentsMay 9, 2019
K182662boston endo surgical techNAV PAK Needle, NIM NAV PAK NeedleApril 10, 2019
K181559magstim companyNeurosign V4 Intraoperative Nerve MonitorNovember 9, 2018
K180542boston endo surgical techNIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeAugust 22, 2018
K173526medos international sarlSENTIO MMG Gen 2April 5, 2018
K173134medos international sarlSENTIO MMG Pedicle Access NeedlesMarch 22, 2018
K171807stryker corporationES2 Neuromonitoring Accessory InstrumentsJuly 18, 2017
K162313nu vasive, incorporatedNuVasive Next Generation NVM5 SystemMarch 16, 2017
K161893si-boneNeuromonitoring KitOctober 18, 2016
K152747spineguardDSG Threaded Drill SystemJune 10, 2016
K152942nu vasive, incorporatedNuVasiveNVM5 SystemJanuary 13, 2016
K143641nu vasive, incorporatedNuVasive NVM5 SystemMarch 27, 2015