BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TalisMann Neuromodulation System

    K Number: K243678 · Decision Jul 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    23
    Applicant Total
    5
    Review Days
    218

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    Basic Information

    Device Name
    TalisMann Neuromodulation System
    K Number
    K243678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioventus, LLC
    Date Received
    November 27, 2024
    Decision Date
    July 3, 2025
    Product Code
    GZF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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