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510(k) K243636

Neuralytix iD3 System (NTX-9001) by Neuralytix, LLC — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2025
Date Received
November 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

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