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

    SYNTHES STERNAL FIXATION SYSTEM

    K Number: K112689 · Decision Oct 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    41

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    Basic Information

    Device Name
    SYNTHES STERNAL FIXATION SYSTEM
    K Number
    K112689
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes, Inc.
    Date Received
    September 15, 2011
    Decision Date
    October 26, 2011
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Synthes, Inc.

    K Number Device Name
    K131792 SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
    K122647 SYNTHES PATIENT SPECIFIC PLATE
    K113567 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
    K121502 SYNTHES CURVILINEAR DISTRACTION SYSTEM
    K121574 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
    K113251 SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
    K111323 SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS