Atlas FDA

PDQ

36 FDA 510(k) clearances · Product code

168 daysmedian time to decision
274 days90th percentile
36clearances measured

FDA profile

Official device name
Neurosurgical Nerve Locator
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1820
Medical specialty
Ear, Nose, Throat
FDA definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Adverse events (MAUDE)
2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) (K260992)Neuralytix2026-06-25
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (K253580)Tedan Surgical Innovations2026-04-26
Neuralytix iD3 System (NTX-9001) (K243636)Neuralytix, LLC2025-06-26
TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438)Medos International SARL2023-02-10
ATEC IOM Accessory Instruments (K221821)Alphatec Spine, Inc.2022-09-23
PediGuard Threaded (K220160)Spineguard S.A.2022-03-31
Neurosign V4 Intraoperative Nerve Monitor (K203684)Magstim Company, Ltd.2021-03-17
DSG Connect Technology (K201454)Spineguard S.A.2021-02-10
ATEC IOM Accessory Instruments (K191723)Alphatec Spine, Inc.2019-10-18
ALARA Neuro Access Kit (K190163)SurGenTec, LLC2019-07-16
ATEC IOM Accessory Instruments (K182617)Alphatec Spine, Inc.2019-05-09
NAV PAK Needle, NIM NAV PAK Needle (K182662)Boston Endo Surgical Tech,2019-04-10
Neurosign V4 Intraoperative Nerve Monitor (K181559)Magstim Company, Ltd.2018-11-09
NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe (K180542)Boston Endo Surgical Tech,2018-08-22
SENTIO MMG Gen 2 (K173526)Medos International SARL2018-04-05
SENTIO MMG Pedicle Access Needles (K173134)Medos International SARL2018-03-22
ES2 Neuromonitoring Accessory Instruments (K171807)Stryker Corporation2017-07-18
NuVasive Next Generation NVM5 System (K162313)Nu Vasive, Incorporated2017-03-16
Neuromonitoring Kit (K161893)SI-BONE, Inc.2016-10-18
DSG Threaded Drill System (K152747)Spineguard S.A.2016-06-10
NuVasiveNVM5 System (K152942)Nu Vasive, Incorporated2016-01-13
NuVasive NVM5 System (K143641)Nu Vasive, Incorporated2015-03-27
Nerve Monitoring Cable System (K142438)Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)2015-03-05
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 (K143159)Spineguard S.A.2015-01-23
NUVASIVE NVM5 SYSTEM (K141968)Nuvasive, Inc.2014-11-14
PHANTOM XL INSULATED DILATORS (K140088)Tedan Surgical Innovations, LLC2014-09-25
SENTIO MMG (K131304)Innovative Surgical Solutions, LLC ("Iss")2014-05-29
NUVASIVE NVM5 SYSTEM (K132694)Nu Vasive, Incorporated2014-05-16
NUVASIVE EMG ENDOTRACHEAL TUBE (K133530)Nu Vasive, Incorporated2014-05-02
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (K132138)Rhythmlink International, LLC2014-04-11
BIOMET ACCESS SYSTEM (K132373)Biomet Spine (Aka Ebi, LLC)2014-03-27
PEDIGUARD NERVE DETECTOR SYSTEM (K123390)Spineguard S.A.2013-08-08
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K130806)Neurovision Medical Products, Inc.2013-07-12
DILATOR TUBE SET (K120590)Koros USA, Inc.2013-05-07
NUVASIVE NVM5 SYSTEM (K123307)Nuvasive, Inc.2013-04-23
CADWELL DISPOSABLE PROBE HANDLE (K123589)Cadwell2013-03-19

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Every clearance here is in the API, with alerts when new ones post.