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510(k) K243636

Device
Neuralytix iD3 System (NTX-9001)
Applicant
Neuralytix, LLC
510(k) number
K243636
Product code
PDQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-26
Date received
2024-11-25
Regulation
874.1820
Classification name
Neurosurgical Nerve Locator
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Christopher Wybo
Address
138 S Park Sq. Suite 203 Fruita CO US 81521 81521

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.2019-05-09
K182662NAV PAK Needle, NIM NAV PAK NeedleBoston Endo Surgical Tech,2019-04-10
K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.2018-11-09
K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,2018-08-22
K173526SENTIO MMG Gen 2Medos International SARL2018-04-05
K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL2018-03-22
K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation2017-07-18