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

    STRYKER PATIENT SPECIFIC POLYMER IMPLANT

    K Number: K043250 · Decision Apr 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    12
    Review Days
    143

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    Basic Information

    Device Name
    STRYKER PATIENT SPECIFIC POLYMER IMPLANT
    K Number
    K043250
    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
    Stryker Leibinger
    Date Received
    November 23, 2004
    Decision Date
    April 15, 2005
    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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