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

    MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT

    K Number: K131673 · Decision Oct 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    234
    Same Product Code
    483
    Applicant Total
    83
    Review Days
    118

    Basic Information

    Device Name
    MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
    K Number
    K131673
    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 USA, INC.
    Date Received
    June 7, 2013
    Decision Date
    October 3, 2013
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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