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

    PILLAR MALAR IMPLANT

    K Number: K992240 · Decision Nov 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    5
    Review Days
    143

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    Basic Information

    Device Name
    PILLAR MALAR IMPLANT
    K Number
    K992240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pillar Surgical, Inc.
    Date Received
    July 2, 1999
    Decision Date
    November 22, 1999
    Product Code
    LZK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LZK Implant, Malar

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    Other Clearances by Pillar Surgical, Inc.

    K Number Device Name
    K002633 SILMAX PECTORAL IMPLANT
    K002629 SILMAX CONTOUR CARVING BLOCK IMPLANT
    K992239 PILLAR CHIN IMPLANT
    K992242 PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS