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

    AOS Anterolateral Proximal Humeral Plate

    K Number: K160409 · Decision Mar 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    23
    Review Days
    28

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    Basic Information

    Device Name
    AOS Anterolateral Proximal Humeral Plate
    K Number
    K160409
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Orthopaedic Solutions, Inc.
    Date Received
    February 16, 2016
    Decision Date
    March 15, 2016
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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    Other Clearances by Advanced Orthopaedic Solutions, Inc.

    K Number Device Name
    K202489 AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
    K202099 AOS Galileo™ Trochanteric Nail System
    K191598 AOS ES Retrograde Femoral Nail
    K143204 AOS Clavicle Intramedullary Device
    K141912 AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
    K141228 AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
    K133081 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
    K132005 RETROGRADE FEMORAL NAIL
    K123569 ANTEGRADE FEMORAL NAIL
    K130625 12MM AND 13MM TIBIAL NAILS
    Search all 23 clearances from Advanced Orthopaedic Solutions, Inc. →