Product code PDQ
- Device name
- Neurosurgical Nerve Locator
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.1820
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | 2026-04-26 |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025-06-26 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023-02-10 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022-09-23 |
| K220160 | PediGuard Threaded | Spineguard S.A. | 2022-03-31 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021-03-17 |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021-02-10 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-10-18 |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019-07-16 |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-05-09 |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | 2019-04-10 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018-11-09 |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | 2018-08-22 |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018-04-05 |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018-03-22 |
| K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017-07-18 |
| K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017-03-16 |
| K161893 | Neuromonitoring Kit | SI-BONE, Inc. | 2016-10-18 |
| K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016-06-10 |
| K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016-01-13 |
| K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015-03-27 |
| K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015-03-05 |
| 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 Cu... | Spineguard S.A. | 2015-01-23 |
| K141968 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2014-11-14 |
| K140088 | PHANTOM XL INSULATED DILATORS | Tedan Surgical Innovations, LLC | 2014-09-25 |
| K131304 | SENTIO MMG | Innovative Surgical Solutions, LLC ("Iss") | 2014-05-29 |
| K132694 | NUVASIVE NVM5 SYSTEM | Nu Vasive, Incorporated | 2014-05-16 |
| K133530 | NUVASIVE EMG ENDOTRACHEAL TUBE | Nu Vasive, Incorporated | 2014-05-02 |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | Rhythmlink International, LLC | 2014-04-11 |
| K132373 | BIOMET ACCESS SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2014-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M68980801D160 | Fresh Whole Blood Donor Transfusion Set | Safeguard US Operating, LLC | 2026-05-04 |
| 10705034604527 | TELIGEN | Medos International Sàrl | 2024-02-10 |
| 10840199500007 | Dilator Tube Set, Single Use, Sterile | KOROS U.S.A., INC. | 2022-01-31 |
| 10705034543116 | SENTIO | Medos International Sàrl | 2020-05-28 |
| 10705034543123 | SENTIO | Medos International Sàrl | 2020-05-28 |
| 10705034534787 | SENTIO | Medos International Sàrl | 2018-10-08 |
| 10705034534763 | SENTIO | Medos International Sàrl | 2018-10-08 |
| 20705034534746 | SENTIO | Medos International Sàrl | 2018-10-08 |
| 10705034534923 | SENTIO | Medos International Sàrl | 2018-10-08 |
| 10705034534800 | SENTIO | Medos International Sàrl | 2018-10-08 |
| 10705034534794 | SENTIO | Medos International Sàrl | 2018-10-08 |
| B006NVTKITC752 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006NVTKITC652 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700XS52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700S52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700M52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700L52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCSF52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCS52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCMF52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCM52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCLF52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE700DCL52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600X5S52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600X4S52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600X3S52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600S52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600ML52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600M52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |
| B006LTE600L52 | NONE | Neurovision Medical Products, Inc. | 2016-09-24 |