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

    AOS Small Fragment Plating System

    K Number: K161913 · Decision Nov 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    115

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    Basic Information

    Device Name
    AOS Small Fragment Plating System
    K Number
    K161913
    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. (Aos)
    Date Received
    July 12, 2016
    Decision Date
    November 4, 2016
    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 Advanced Orthopaedic Solutions, Inc. (Aos)

    K Number Device Name
    K181035 AOS Small Fragment Plating System Lite
    K171606 AOS Anterolateral Proximal Humeral Plate
    K163014 AOS Small Bone Nailing System