PDQ · Class II · 21 CFR 874.1820

FDA Product Code PDQ: Neurosurgical Nerve Locator

To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.

Leading manufacturers include Nu Vasive, Incorporated, Alphatec Spine, Inc. and Medos International SARL.

36
Total
36
Cleared
175d
Avg days
2013
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 155d avg (recent)

FDA 510(k) Cleared Neurosurgical Nerve Locator Devices (Product Code PDQ)

36 devices
1–24 of 36
Cleared Apr 26, 2026
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S)
K253580
Tedan Surgical Innovations
Neurology · 160d
Cleared Jun 26, 2025
Neuralytix iD3 System (NTX-9001)
K243636
Neuralytix, LLC
Neurology · 213d
Cleared Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
K223438
Medos International SARL
Neurology · 88d
Cleared Sep 23, 2022
ATEC IOM Accessory Instruments
K221821
Alphatec Spine, Inc.
Neurology · 92d
Cleared Mar 31, 2022
PediGuard Threaded
K220160
Spineguard S.A.
Neurology · 71d
Cleared Mar 17, 2021
Neurosign V4 Intraoperative Nerve Monitor
K203684
Magstim Company, Ltd.
Neurology · 90d
Cleared Feb 10, 2021
DSG Connect Technology
K201454
Spineguard S.A.
Neurology · 254d
Cleared Oct 18, 2019
ATEC IOM Accessory Instruments
K191723
Alphatec Spine, Inc.
Neurology · 113d
Cleared Jul 16, 2019
ALARA Neuro Access Kit
K190163
SurGenTec, LLC
Neurology · 166d
Cleared May 09, 2019
ATEC IOM Accessory Instruments
K182617
Alphatec Spine, Inc.
Neurology · 227d
Cleared Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662
Boston Endo Surgical Tech,
Neurology · 197d
Cleared Nov 09, 2018
Neurosign V4 Intraoperative Nerve Monitor
K181559
Magstim Company, Ltd.
Neurology · 149d
Cleared Aug 22, 2018
NIM PAK Needle
K180542
Boston Endo Surgical Tech,
Neurology · 174d
Cleared Apr 05, 2018
SENTIO MMG Gen 2
K173526
Medos International SARL
Neurology · 142d
Cleared Mar 22, 2018
SENTIO MMG Pedicle Access Needles
K173134
Medos International SARL
Neurology · 174d
Cleared Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
K171807
Stryker Corporation
Neurology · 29d
Cleared Mar 16, 2017
NuVasive Next Generation NVM5 System
K162313
Nu Vasive, Incorporated
Neurology · 210d
Cleared Jan 13, 2016
NuVasiveNVM5 System
K152942
Nu Vasive, Incorporated
Neurology · 100d
Cleared Mar 27, 2015
NuVasive NVM5 System
K143641
Nu Vasive, Incorporated
Neurology · 95d
Cleared Nov 14, 2014
NUVASIVE NVM5 SYSTEM
K141968
Nuvasive, Inc.
Neurology · 116d
Cleared May 16, 2014
NUVASIVE NVM5 SYSTEM
K132694
Nu Vasive, Incorporated
Neurology · 260d
Cleared May 02, 2014
NUVASIVE EMG ENDOTRACHEAL TUBE
K133530
Nu Vasive, Incorporated
Neurology · 168d
Cleared Apr 23, 2013
NUVASIVE NVM5 SYSTEM
K123307
Nuvasive, Inc.
Neurology · 181d

About Product Code PDQ - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code PDQ since 2013, with 36 receiving FDA clearance (average review time: 175 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PDQ Product Code

FDA review times for PDQ submissions have been consistent, averaging 155 days recently vs 176 days historically.

PDQ devices are reviewed by the Neurology panel. Browse all Neurology devices →