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

    Helios Dura Regeneration Matrix

    K Number: K250420 · Decision May 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    Helios Dura Regeneration Matrix
    K Number
    K250420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helios Biomedical, Inc.
    Date Received
    February 13, 2025
    Decision Date
    May 14, 2025
    Product Code
    GXQ
    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
    GXQ Dura Substitute

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    Other Clearances by Helios Biomedical, Inc.

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