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

    TRAUMACEM™ V+ Injectable Bone Cement

    K Number: K170802 · Decision Sep 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    71
    Applicant Total
    45
    Review Days
    195

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    Basic Information

    Device Name
    TRAUMACEM™ V+ Injectable Bone Cement
    K Number
    K170802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    March 17, 2017
    Decision Date
    September 28, 2017
    Product Code
    LOD
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOD Bone Cement

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