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

    CONCERT RADIOPAQUE BONE CEMENT

    K Number: K013755 · Decision Feb 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    87

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    Basic Information

    Device Name
    CONCERT RADIOPAQUE BONE CEMENT
    K Number
    K013755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immedica, Inc.
    Date Received
    November 13, 2001
    Decision Date
    February 8, 2002
    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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