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

    SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS

    K Number: K111323 · Decision Nov 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    8
    Review Days
    189

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    Basic Information

    Device Name
    SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
    K Number
    K111323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes, Inc.
    Date Received
    May 11, 2011
    Decision Date
    November 16, 2011
    Product Code
    KKY
    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
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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    Other Clearances by Synthes, Inc.

    K Number Device Name
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    K113567 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
    K121502 SYNTHES CURVILINEAR DISTRACTION SYSTEM
    K121574 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
    K113251 SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
    K112689 SYNTHES STERNAL FIXATION SYSTEM