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

    BONE SOURCE HAC RAPID SETTING CEMENT

    K Number: K043334 · Decision Feb 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    74
    Review Days
    68

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    Basic Information

    Device Name
    BONE SOURCE HAC RAPID SETTING CEMENT
    K Number
    K043334
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    December 3, 2004
    Decision Date
    February 9, 2005
    Product Code
    GXP
    Advisory Committee
    Neurology
    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
    GXP Methyl Methacrylate For Cranioplasty

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