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.
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| 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 |
Top Applicants
- Nu Vasive, Incorporated — 5 clearances
- Spineguard S.A. — 5 clearances
- Alphatec Spine, Inc. — 3 clearances
- Medos International SARL — 3 clearances
- Boston Endo Surgical Tech, — 2 clearances
