Neurosurgical Nerve Locator
FDA product code PDQ · Class II (moderate risk) · 21 CFR 874.1820 · Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
36510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Spineguard S.A. 5
- Nu Vasive, Incorporated 5
- Alphatec Spine, Inc. 3
- Medos International SARL 3
- TeDan Surgical Innovations LLC 2
- Neuralytix 2
- The Magstim Company , Ltd. 2
- Boston Endo Surgical Tech, 2
- Nuvasive, Inc. 2
- Innovative Surgical Solutions, LLC ("Iss") 1
- Cadwell 1
- Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) 1
- SI-BONE, Inc. 1
- Stryker Corporation 1
- Rhythmlink International, LLC 1
- Biomet Spine (Aka Ebi, LLC) 1
- Neurovision Medical Products Inc 1
- Koros USA, Inc. 1
- SurGenTec, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…PDQ · Traditional | Neuralytix | 06/25/2026SE |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…PDQ · Traditional | Tedan Surgical Innovations | 04/26/2026SE |
| K243636 | Neuralytix iD3 System (NTX-9001)PDQ · Traditional | Neuralytix, LLC | 06/26/2025SE |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ · Traditional | Medos International SARL | 02/10/2023SE |
| K221821 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 09/23/2022SE |
| K220160 | PediGuard ThreadedPDQ · Traditional | Spineguard S.A. | 03/31/2022SE |
| K203684 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | Magstim Company, Ltd. | 03/17/2021SE |
| K201454 | DSG Connect TechnologyPDQ · Traditional | Spineguard S.A. | 02/10/2021SE |
| K191723 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 10/18/2019SE |
| K190163 | ALARA Neuro Access KitPDQ · Traditional | SurGenTec, LLC | 07/16/2019SE |
| K182617 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 05/09/2019SE |
| K182662 | NAV PAK Needle, NIM NAV PAK NeedlePDQ · Traditional | Boston Endo Surgical Tech, | 04/10/2019SE |
| K181559 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | Magstim Company, Ltd. | 11/09/2018SE |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbePDQ · Traditional | Boston Endo Surgical Tech, | 08/22/2018SE |
| K173526 | SENTIO MMG Gen 2PDQ · Traditional | Medos International SARL | 04/05/2018SE |
| K173134 | SENTIO MMG Pedicle Access NeedlesPDQ · Traditional | Medos International SARL | 03/22/2018SE |
| K171807 | ES2 Neuromonitoring Accessory InstrumentsPDQ · Special | Stryker Corporation | 07/18/2017SE |
| K162313 | NuVasive Next Generation NVM5 SystemPDQ · Traditional | Nu Vasive, Incorporated | 03/16/2017SE |
| K161893 | Neuromonitoring KitPDQ · Traditional | SI-BONE, Inc. | 10/18/2016SE |
| K152747 | DSG Threaded Drill SystemPDQ · Traditional | Spineguard S.A. | 06/10/2016SE |
| K152942 | NuVasiveNVM5 SystemPDQ · Traditional | Nu Vasive, Incorporated | 01/13/2016SE |
| K143641 | NuVasive NVM5 SystemPDQ · Traditional | Nu Vasive, Incorporated | 03/27/2015SE |
| K142438 | Nerve Monitoring Cable SystemPDQ · Traditional | Pioneer Surgical Technology, Inc. (Rti Surgical… | 03/05/2015SE |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…PDQ · Traditional | Spineguard S.A. | 01/23/2015SE |
| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | Nuvasive, Inc. | 11/14/2014SE |
| K140088 | Phantom XL Insulated DilatorsPDQ · Traditional | Tedan Surgical Innovations, LLC | 09/25/2014SE |
| K131304 | Sentio MMGPDQ · Traditional | Innovative Surgical Solutions, LLC ("Iss") | 05/29/2014SE |
| K132694 | Nuvasive NVM5 SystemPDQ · Traditional | Nu Vasive, Incorporated | 05/16/2014SE |
| K133530 | Nuvasive Emg Endotracheal TubePDQ · Traditional | Nu Vasive, Incorporated | 05/02/2014SE |
| K132138 | Rhythmlink Disposable Concentric Stimulating ProbePDQ · Traditional | Rhythmlink International, LLC | 04/11/2014SE |
| K132373 | Biomet Access SystemPDQ · Traditional | Biomet Spine (Aka Ebi, LLC) | 03/27/2014SE |
| K123390 | Pediguard Nerve Detector SystemPDQ · Traditional | Spineguard S.A. | 08/08/2013SE |
| K130806 | Neurovision Ink Printed Endotracheal Tube ElectrodePDQ · Special | Neurovision Medical Products, Inc. | 07/12/2013SE |
| K120590 | Dilator Tube SetPDQ · Traditional | Koros USA, Inc. | 05/07/2013SE |
| K123307 | Nuvasive NVM5 SystemPDQ · Traditional | Nuvasive, Inc. | 04/23/2013SE |
| K123589 | Cadwell Disposable Probe HandlePDQ · Traditional | Cadwell | 03/19/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2884-2020 Class II | Neurosign V4 Intraoperative Nerve monitor family of devices.Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable… | The Magstim Company Limited | 06/23/2020Terminated |
| Z-2684-2020 Class II | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633…The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery… | NuVasive Inc | 06/10/2020Terminated |