FDA Product Code PDQ: Neurosurgical Nerve Locator
To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
Leading manufacturers include Medos International SARL, Alphatec Spine, Inc. and Boston Endo Surgical Tech,.
35
Total
35
Cleared
177d
Avg days
2013
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
187d avg (recent)
FDA 510(k) Cleared Neurosurgical Nerve Locator Devices (Product Code PDQ)
35 devices
Cleared
Apr 26, 2026
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S)
Tedan Surgical Innovations
Neurology
160d
Cleared
Jun 26, 2025
Neuralytix iD3 System (NTX-9001)
Neuralytix, LLC
Neurology
213d
Cleared
Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
Medos International SARL
Neurology
88d
Cleared
Sep 23, 2022
ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
Neurology
92d
Cleared
Mar 31, 2022
PediGuard Threaded
Spineguard S.A.
Neurology
71d
Cleared
Mar 17, 2021
Neurosign V4 Intraoperative Nerve Monitor
Magstim Company, Ltd.
Neurology
90d
Cleared
Feb 10, 2021
DSG Connect Technology
Spineguard S.A.
Neurology
254d
Cleared
Oct 18, 2019
ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
Neurology
113d
Cleared
Jul 16, 2019
ALARA Neuro Access Kit
SurGenTec, LLC
Neurology
166d
Cleared
May 09, 2019
ATEC IOM Accessory Instruments
Alphatec Spine, Inc.
Neurology
227d
Cleared
Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
Boston Endo Surgical Tech,
Neurology
197d
Cleared
Nov 09, 2018
Neurosign V4 Intraoperative Nerve Monitor
Magstim Company, Ltd.
Neurology
149d
Cleared
Aug 22, 2018
NIM PAK Needle
Boston Endo Surgical Tech,
Neurology
174d
Cleared
Apr 05, 2018
SENTIO MMG Gen 2
Medos International SARL
Neurology
142d
Cleared
Mar 22, 2018
SENTIO MMG Pedicle Access Needles
Medos International SARL
Neurology
174d
Cleared
Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
Stryker Corporation
Neurology
29d
Cleared
Mar 16, 2017
NuVasive Next Generation NVM5 System
Nu Vasive, Incorporated
Neurology
210d
About Product Code PDQ - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code PDQ since 2013, with 35 receiving FDA clearance (average review time: 177 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - PDQ Product Code
FDA review times for PDQ submissions have been consistent, averaging 187 days recently vs 176 days historically.
PDQ devices are reviewed by the Neurology panel. Browse all Neurology devices →