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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K260992
Device Name iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
Applicant
Neuralytix
138 S Park Sq.
Suite 203
Fruita,  CO  81521
Applicant Contact Brian Dean
Correspondent
Neuralytix
138 S Park Sq.
Suite 203
Fruita,  CO  81521
Correspondent Contact Brian Dean
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received03/26/2026
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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