Data / Medical devices / United States / Neuralytix LLC
Neuralytix LLC: FDA-registered device maker in Fruita, CO, United States, 2 510(k) clearances
Neuralytix LLC is registered with the FDA (registration 3042364673) in Fruita, CO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042364673
- Address
- 138 S Park Sq Ste 203, Fruita, CO, United States, 81521
- Owner or operator
- NEURALYTIX LLC (10094149)
- Roles
- Specification developer
- First device listed
- November 17, 2025
- Registered through
- 2027
- Brand names listed
- Neuralytix iD3 System, iD3 Ball Tip Stim Probe, iD3 Nav Ball Tip Probe, iD3 Nav Decompression Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurosurgical Nerve Locator | PDQ | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | PDQ | Substantially Equivalent | Neuralytix | accessdata.fda.gov |
| June 26, 2025 | K243636 | Neuralytix iD3 System (NTX-9001) | PDQ | Substantially Equivalent | Neuralytix, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.