NEURALYTIX LLC

FDA Device Registration & Listing · Fruita, CO, US · Registration 3042364673

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042364673
FEI Number
3042364673
Entity Name
NEURALYTIX LLC
City/State/Country
Fruita, CO, US
Establishment Address
138 S Park Sq Ste 203, Fruita, CO 81521, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
NEURALYTIX LLC (Owner Number: 10094149)
Owner / Operator Contact Address
138 S Park Square, STE 203, Fruita, CO 81521, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243636
PMA Number
N/A

All Registered Proprietary Names

Neuralytix iD3 System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-11-17
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-11-17

Official Correspondent

CHRISTOPHER WYBO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEURALYTIX LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K833646 Edward Weck, Inc. PULSATRON NERVE LOCATOR/STIMULATOR 1984-02-10
K150005 Ndi Medical, LLC Checkpoint, Checkpoint Head & Neck 2015-02-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042364673. Last updated year: 2026. Please use registration number 3042364673 when referencing this establishment in official correspondence.
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