FDA Product Code
FDA Product Code PDQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.1820
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | 2026-06-25 | Traditional | PDF ↗ |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | 2026-04-26 | Traditional | PDF ↗ |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025-06-26 | Traditional | PDF ↗ |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023-02-10 | Traditional | PDF ↗ |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022-09-23 | Traditional | PDF ↗ |
| K220160 | PediGuard Threaded | Spineguard S.A. | 2022-03-31 | Traditional | PDF ↗ |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021-03-17 | Traditional | PDF ↗ |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021-02-10 | Traditional | PDF ↗ |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-10-18 | Traditional | PDF ↗ |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019-07-16 | Traditional | PDF ↗ |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-05-09 | Traditional | PDF ↗ |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | 2019-04-10 | Traditional | PDF ↗ |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018-11-09 | Traditional | PDF ↗ |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | 2018-08-22 | Traditional | PDF ↗ |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018-04-05 | Traditional | PDF ↗ |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018-03-22 | Traditional | PDF ↗ |
| K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017-07-18 | Special | PDF ↗ |
| K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017-03-16 | Traditional | PDF ↗ |
| K161893 | Neuromonitoring Kit | SI-BONE, Inc. | 2016-10-18 | Traditional | PDF ↗ |
| K152747 | DSG Threaded Drill System | Spineguard S.A. | 2016-06-10 | Traditional | PDF ↗ |
| K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016-01-13 | Traditional | PDF ↗ |
| K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015-03-27 | Traditional | PDF ↗ |
| K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015-03-05 | Traditional | PDF ↗ |
| 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. | 2015-01-23 | Traditional | PDF ↗ |
| K141968 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2014-11-14 | Traditional | PDF ↗ |
| K140088 | PHANTOM XL INSULATED DILATORS | Tedan Surgical Innovations, LLC | 2014-09-25 | Traditional | PDF ↗ |
| K131304 | SENTIO MMG | Innovative Surgical Solutions, LLC ("Iss") | 2014-05-29 | Traditional | PDF ↗ |
| K132694 | NUVASIVE NVM5 SYSTEM | Nu Vasive, Incorporated | 2014-05-16 | Traditional | PDF ↗ |
| K133530 | NUVASIVE EMG ENDOTRACHEAL TUBE | Nu Vasive, Incorporated | 2014-05-02 | Traditional | PDF ↗ |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | Rhythmlink International, LLC | 2014-04-11 | Traditional | PDF ↗ |
| K132373 | BIOMET ACCESS SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2014-03-27 | Traditional | PDF ↗ |
| K123390 | PEDIGUARD NERVE DETECTOR SYSTEM | Spineguard S.A. | 2013-08-08 | Traditional | PDF ↗ |
| K130806 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | Neurovision Medical Products, Inc. | 2013-07-12 | Special | PDF ↗ |
| K120590 | DILATOR TUBE SET | Koros USA, Inc. | 2013-05-07 | Traditional | PDF ↗ |
| K123307 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2013-04-23 | Traditional | PDF ↗ |
| K123589 | CADWELL DISPOSABLE PROBE HANDLE | Cadwell | 2013-03-19 | Traditional | PDF ↗ |
Product code PDQ · Class II · Ear, Nose, Throat. Data: openFDA.