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510(k) Data Aggregation

    K Number
    K250420
    Device Name
    Helios Dura Regeneration Matrix
    Manufacturer
    Helios Biomedical Inc.
    Date Cleared
    2025-05-14

    (90 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Helios Biomedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.
    Device Description
    Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.
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