Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820) → PDQ — Neurosurgical Nerve Locator # PDQ · Neurosurgical Nerve Locator _Ear, Nose, Throat · 21 CFR 874.1820 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ ## Overview - **Product Code:** PDQ - **Device Name:** Neurosurgical Nerve Locator - **Regulation:** [21 CFR 874.1820](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1820) - **Device Class:** 2 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K243636.md) | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | Jun 26, 2025 | SESE | | [K223438](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K223438.md) | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | Feb 10, 2023 | SESE | | [K221821](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K221821.md) | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Sep 23, 2022 | SESE | | [K220160](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K220160.md) | PediGuard Threaded | Spineguard S.A. | Mar 31, 2022 | SESE | | [K203684](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K203684.md) | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Mar 17, 2021 | SESE | | [K201454](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K201454.md) | DSG Connect Technology | Spineguard S.A. | Feb 10, 2021 | SESE | | [K191723](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K191723.md) | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | Oct 18, 2019 | SESE | | [K190163](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K190163.md) | ALARA Neuro Access Kit | SurGenTec, LLC | Jul 16, 2019 | SESE | | [K182617](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K182617.md) | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | May 9, 2019 | SESE | | [K182662](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K182662.md) | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | Apr 10, 2019 | SESE | | [K181559](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K181559.md) | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | Nov 9, 2018 | SESE | | [K180542](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K180542.md) | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | Aug 22, 2018 | SESE | | [K173526](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K173526.md) | SENTIO MMG Gen 2 | Medos International SARL | Apr 5, 2018 | SESE | | [K173134](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K173134.md) | SENTIO MMG Pedicle Access Needles | Medos International SARL | Mar 22, 2018 | SESE | | [K171807](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K171807.md) | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | Jul 18, 2017 | SESE | | [K162313](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K162313.md) | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | Mar 16, 2017 | SESE | | [K161893](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K161893.md) | Neuromonitoring Kit | SI-BONE, Inc. | Oct 18, 2016 | SESE | | [K152747](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K152747.md) | DSG Threaded Drill System | Spineguard S.A. | Jun 10, 2016 | SESE | | [K152942](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K152942.md) | NuVasiveNVM5 System | Nu Vasive, Incorporated | Jan 13, 2016 | SESE | | [K143641](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ/K143641.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/PDQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com