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

    PROGENIX PLUS

    K Number: K081950 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    14
    Applicant Total
    99
    Review Days
    9

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    Basic Information

    Device Name
    PROGENIX PLUS
    K Number
    K081950
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek, Inc.
    Date Received
    July 9, 2008
    Decision Date
    July 18, 2008
    Product Code
    NUN
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUN Bone Grafting Material, Human Source

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