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FDA 510(k)

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

K-Number: K260992 · 2026-06-25

ApplicantNeuralytix
Decision Date2026-06-25
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) is the device name listed in this FDA 510(k) record. The listed applicant is Neuralytix. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260992. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)?

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Neuralytix. The 510(k) number is K260992.

When did iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) receive FDA 510(k) clearance?

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260992.

Who is the listed applicant for iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)?

The FDA 510(k) record lists Neuralytix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)?

The FDA product code for iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) is PDQ.

Other records listing Neuralytix as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243636Neuralytix iD3 System (NTX-9001)

Related Devices (Code: PDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical InnovationsK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARLK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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