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510(k) Data Aggregation

    K Number
    K253363

    Validate with FDA (Live)

    Device Name
    NeuroSpan Bridge
    Manufacturer
    Auxilium Biotechnologies, Inc.
    Date Cleared
    2026-01-17

    (109 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K011168
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NeuroSpan Bridge is indicated for the repair of peripheral nerve discontinuities where a tensionless repair can be made (i.e., by flexion of the extremity).

    Device Description

    The NeuroSpan Bridge is a biodegradable micro-channeled implant for the repair of peripheral nerve discontinuities. The NeuroSpan Bridge provides a protective environment for peripheral nerve repair after injury, and is designed to be an interface between the two transected nerve stumps in order to provide a bridge for axonal growth across the nerve gap.

    The NeuroSpan Bridge is flexible while being strong enough to hold sutures. The NeuroSpan Bridge is made from polycaprolactone (PCL) and features overhangs on both ends for suturing, with marks showing the overhang depth. The overhang allows the surgeon to place the nerve stump with apposition to the internal microchannel structure and suture without damaging it. The NeuroSpan Bridge has multiple channels throughout the device for axon growth. The NeuroSpan Bridge is provided sterile, for single use, and in multiple diameter and length variations.

    AI/ML Overview

    N/A

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