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FDA 510(k)

NeuroSpan Bridge

K-Number: K253363 · 2026-01-17

ApplicantAuxilium Biotechnologies, Inc.
Decision Date2026-01-17
Product CodeJXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroSpan Bridge is a medical device manufactured by Auxilium Biotechnologies, Inc.. It received FDA 510(k) clearance on 2026-01-17 under approval number K253363. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroSpan Bridge?

NeuroSpan Bridge is a medical device that received FDA 510(k) clearance on 2026-01-17. It is manufactured by Auxilium Biotechnologies, Inc.. The 510(k) number is K253363.

When was NeuroSpan Bridge approved by the FDA?

NeuroSpan Bridge received FDA 510(k) clearance on 2026-01-17, under approval number K253363.

What company makes NeuroSpan Bridge?

NeuroSpan Bridge is manufactured by Auxilium Biotechnologies, Inc..

What is the FDA product code for NeuroSpan Bridge?

The FDA product code for NeuroSpan Bridge is JXI.

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Official Source

View on FDA Database →

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

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