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

    CLEARED UNDER GRAFTON II EDBM

    K Number: K122513 · Decision Mar 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    30
    Applicant Total
    99
    Review Days
    201

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    Basic Information

    Device Name
    CLEARED UNDER GRAFTON II EDBM
    K Number
    K122513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek, Inc.
    Date Received
    August 17, 2012
    Decision Date
    March 6, 2013
    Product Code
    MBP
    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
    MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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