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Panels › Ear, Nose, Throat › Product code PDQ · Class 2

Neurosurgical Nerve Locator

Regulation 874.1820

2510(k)s in 12 months (36 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in PDQ

Company510(k)sRecalls
Nu Vasive, Incorporated50
Spineguard S.A.50
Alphatec Spine, Inc.30
Magstim Company, Ltd.21
Medos International SARL30
Nuvasive, Inc.21
Boston Endo Surgical Tech,20
Neuralytix20
Tedan Surgical Innovations20
Biomet Spine (Aka Ebi, LLC)10
Decided510(k)Device and applicantCode
Jun 25, 2026K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
Neuralytix
PDQ
Apr 26, 2026K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Tedan Surgical Innovations
PDQ
Jun 26, 2025K243636Neuralytix iD3 System (NTX-9001)
Neuralytix, LLC
PDQ
Feb 10, 2023K223438TELIGEN System Peripheral Motor Nerve Stimulation Indications
Medos International SARL, CH
PDQ
Sep 23, 2022K221821ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
PDQ
Mar 31, 2022K220160PediGuard Threaded
Spineguard S.A., FR
PDQ
Mar 17, 2021K203684Neurosign V4 Intraoperative Nerve Monitor
Magstim Company, Ltd., GB
PDQ
Feb 10, 2021K201454DSG Connect Technology
Spineguard S.A., FR
PDQ
Oct 18, 2019K191723ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
PDQ
Jul 16, 2019K190163ALARA Neuro Access Kit
SurGenTec, LLC
PDQ
May 9, 2019K182617ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
PDQ
Apr 10, 2019K182662NAV PAK Needle, NIM NAV PAK Needle
Boston Endo Surgical Tech,
PDQ
Nov 9, 2018K181559Neurosign V4 Intraoperative Nerve Monitor
Magstim Company, Ltd., GB
PDQ
Aug 22, 2018K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
Boston Endo Surgical Tech,
PDQ
Apr 5, 2018K173526SENTIO MMG Gen 2
Medos International SARL, CH
PDQ
Mar 22, 2018K173134SENTIO MMG Pedicle Access Needles
Medos International SARL, CH
PDQ
Jul 18, 2017K171807ES2 Neuromonitoring Accessory Instruments
Stryker Corporation
PDQ
Mar 16, 2017K162313NuVasive Next Generation NVM5 System
Nu Vasive, Incorporated
PDQ
Oct 18, 2016K161893Neuromonitoring Kit
SI-BONE, Inc.
PDQ
Jun 10, 2016K152747DSG Threaded Drill System
Spineguard S.A., FR
PDQ
Jan 13, 2016K152942NuVasiveNVM5 System
Nu Vasive, Incorporated
PDQ
Mar 27, 2015K143641NuVasive NVM5 System
Nu Vasive, Incorporated
PDQ
Mar 5, 2015K142438Nerve Monitoring Cable System
Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
PDQ
Jan 23, 2015K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Ha
Spineguard S.A., FR
PDQ
Nov 14, 2014K141968NUVASIVE NVM5 SYSTEM
Nuvasive, Inc.
PDQ
Sep 25, 2014K140088PHANTOM XL INSULATED DILATORS
Tedan Surgical Innovations, LLC
PDQ
May 29, 2014K131304SENTIO MMG
Innovative Surgical Solutions, LLC ("Iss")
PDQ
May 16, 2014K132694NUVASIVE NVM5 SYSTEM
Nu Vasive, Incorporated
PDQ
May 2, 2014K133530NUVASIVE EMG ENDOTRACHEAL TUBE
Nu Vasive, Incorporated
PDQ
Apr 11, 2014K132138RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
Rhythmlink International, LLC
PDQ
Mar 27, 2014K132373BIOMET ACCESS SYSTEM
Biomet Spine (Aka Ebi, LLC)
PDQ
Aug 8, 2013K123390PEDIGUARD NERVE DETECTOR SYSTEM
Spineguard S.A.
PDQ
Jul 12, 2013K130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
Neurovision Medical Products, Inc.
PDQ
May 7, 2013K120590DILATOR TUBE SET
Koros USA, Inc.
PDQ
Apr 23, 2013K123307NUVASIVE NVM5 SYSTEM
Nuvasive, Inc.
PDQ
Mar 19, 2013K123589CADWELL DISPOSABLE PROBE HANDLE
Cadwell
PDQ

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