PDQ · Neurosurgical Nerve Locator
Ear, Nose, Throat · 21 CFR 874.1820 · Class 2
Overview
| Product Code | PDQ |
|---|---|
| Device Name | Neurosurgical Nerve Locator |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Classification Rationale
Class II.
Cleared Devices (34)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | Jun 26, 2025 | SESE |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | Feb 10, 2023 | SESE |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Sep 23, 2022 | SESE |
| K220160 | PediGuard Threaded | Spineguard S.A. | Mar 31, 2022 | SESE |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Mar 17, 2021 | SESE |
| K201454 | DSG Connect Technology | Spineguard S.A. | Feb 10, 2021 | SESE |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Oct 18, 2019 | SESE |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | Jul 16, 2019 | SESE |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | May 9, 2019 | SESE |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | Apr 10, 2019 | SESE |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Nov 9, 2018 | SESE |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | Aug 22, 2018 | SESE |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | Apr 5, 2018 | SESE |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | Mar 22, 2018 | SESE |
| K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | Jul 18, 2017 | SESE |
| K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | Mar 16, 2017 | SESE |
| K161893 | Neuromonitoring Kit | SI-BONE, Inc. | Oct 18, 2016 | SESE |
| K152747 | DSG Threaded Drill System | Spineguard S.A. | Jun 10, 2016 | SESE |
| K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | Jan 13, 2016 | SESE |
| K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | Mar 27, 2015 | SESE |
| K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | Mar 5, 2015 | SESE |
| K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS | Spineguard S.A. | Jan 23, 2015 | SESE |
| K141968 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Nov 14, 2014 | SESE |
| K140088 | PHANTOM XL INSULATED DILATORS | Tedan Surgical Innovations, LLC | Sep 25, 2014 | SESE |
| K131304 | SENTIO MMG | Innovative Surgical Solutions, LLC ("Iss") | May 29, 2014 | SESE |
| K132694 | NUVASIVE NVM5 SYSTEM | Nu Vasive, Incorporated | May 16, 2014 | SESE |
| K133530 | NUVASIVE EMG ENDOTRACHEAL TUBE | Nu Vasive, Incorporated | May 2, 2014 | SESE |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | Rhythmlink International, LLC | Apr 11, 2014 | SESE |
| K132373 | BIOMET ACCESS SYSTEM | Biomet Spine (Aka Ebi, LLC) | Mar 27, 2014 | SESE |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | Spineguard S.A. | Aug 8, 2013 | SESE |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | Jul 12, 2013 | SESE |
| K120590 | DILATOR TUBE SET | Koros USA, Inc. | May 7, 2013 | SESE |
| K123307 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | Apr 23, 2013 | SESE |
| K123589 | CADWELL DISPOSABLE PROBE HANDLE | Cadwell | Mar 19, 2013 | SESE |
Top Applicants
- Spineguard S.A. — 5 clearances
- Nu Vasive, Incorporated — 5 clearances
- Medos International SARL — 3 clearances
- Alphatec Spine, Inc. — 3 clearances
- Nuvasive, Inc. — 2 clearances
