PDQ — Neurosurgical Nerve Locator Class II
FDA product code PDQ covers "Neurosurgical Nerve Locator", a Class II medical device regulated under 21 CFR 874.1820. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260992 | neuralytix | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 | June 25, 2026 |
| K253580 | tedan surgical innovations | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, | April 26, 2026 |
| K243636 | neuralytix | Neuralytix iD3 System (NTX-9001) | June 26, 2025 |
| K223438 | medos international sarl | TELIGEN System Peripheral Motor Nerve Stimulation Indications | February 10, 2023 |
| K221821 | alphatec spine | ATEC IOM Accessory Instruments | September 23, 2022 |
| K220160 | spineguard | PediGuard Threaded | March 31, 2022 |
| K203684 | magstim company | Neurosign V4 Intraoperative Nerve Monitor | March 17, 2021 |
| K201454 | spineguard | DSG Connect Technology | February 10, 2021 |
| K191723 | alphatec spine | ATEC IOM Accessory Instruments | October 18, 2019 |
| K190163 | surgentec | ALARA Neuro Access Kit | July 16, 2019 |
| K182617 | alphatec spine | ATEC IOM Accessory Instruments | May 9, 2019 |
| K182662 | boston endo surgical tech | NAV PAK Needle, NIM NAV PAK Needle | April 10, 2019 |
| K181559 | magstim company | Neurosign V4 Intraoperative Nerve Monitor | November 9, 2018 |
| K180542 | boston endo surgical tech | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | August 22, 2018 |
| K173526 | medos international sarl | SENTIO MMG Gen 2 | April 5, 2018 |
| K173134 | medos international sarl | SENTIO MMG Pedicle Access Needles | March 22, 2018 |
| K171807 | stryker corporation | ES2 Neuromonitoring Accessory Instruments | July 18, 2017 |
| K162313 | nu vasive, incorporated | NuVasive Next Generation NVM5 System | March 16, 2017 |
| K161893 | si-bone | Neuromonitoring Kit | October 18, 2016 |
| K152747 | spineguard | DSG Threaded Drill System | June 10, 2016 |