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

    AOS Small Fragment Plating System Lite

    K Number: K181035 · Decision Aug 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    128

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    Basic Information

    Device Name
    AOS Small Fragment Plating System Lite
    K Number
    K181035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Orthopaedic Solutions, Inc. (Aos)
    Date Received
    April 18, 2018
    Decision Date
    August 24, 2018
    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
    K171606 AOS Anterolateral Proximal Humeral Plate
    K163014 AOS Small Bone Nailing System
    K161913 AOS Small Fragment Plating System