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

    STRYKER PATIENT SPECIFIC POLYMER IMPLANT

    K Number: K103010 · Decision Oct 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    30
    Review Days
    14

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    Basic Information

    Device Name
    STRYKER PATIENT SPECIFIC POLYMER IMPLANT
    K Number
    K103010
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp., Dba Stryker Orthopaedics
    Date Received
    October 12, 2010
    Decision Date
    October 26, 2010
    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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