BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Stryker CMF MEDPOR Priority Customized Implant Kit

    K Number: K191916 · Decision Aug 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    21
    Review Days
    29

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    Basic Information

    Device Name
    Stryker CMF MEDPOR Priority Customized Implant Kit
    K Number
    K191916
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger GmbH & Co KG
    Date Received
    July 17, 2019
    Decision Date
    August 15, 2019
    Product Code
    FWP
    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
    FWP Prosthesis, Chin, Internal

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