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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 the device name listed in this FDA 510(k) record. The listed applicant is Auxilium Biotechnologies, Inc.. It received FDA 510(k) clearance on 2026-01-17 under 510(k) 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. The listed applicant is Auxilium Biotechnologies, Inc.. The 510(k) number is K253363.

When did NeuroSpan Bridge receive FDA 510(k) clearance?

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

Who is the listed applicant for NeuroSpan Bridge?

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

What is the FDA product code for NeuroSpan Bridge?

The FDA product code for NeuroSpan Bridge is JXI.

Related Clinical Trials

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.

NCT06529835A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve RepairRECRUITING

Related Devices (Code: JXI)

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.

K260245SILKBridgeKLISBio S.r.l.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair BiosciencesK251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.K233322Mochida Nerve CuffMochida Pharmaceutical Co., Ltd.

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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