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

    MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI

    K Number: K861822 · Decision Jul 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    27
    Review Days
    60

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    Basic Information

    Device Name
    MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
    K Number
    K861822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Valley Forge Scientific Corp.
    Date Received
    May 12, 1986
    Decision Date
    July 11, 1986
    Product Code
    GWO
    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
    GWO Plate, Cranioplasty, Preformed, Alterable

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