BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ArtiFascia

    K Number: K223445 · Decision Aug 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    ArtiFascia
    K Number
    K223445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nurami Medical , Ltd.
    Date Received
    November 14, 2022
    Decision Date
    August 10, 2023
    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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