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

    Internal Joint Stabilizer - Elbow

    K Number: K153208 · Decision Dec 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    18
    Review Days
    56

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    Basic Information

    Device Name
    Internal Joint Stabilizer - Elbow
    K Number
    K153208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skeletal Dynamics, LLC
    Date Received
    November 5, 2015
    Decision Date
    December 31, 2015
    Product Code
    OZI
    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
    OZI Internal Hinged Elbow Fixator

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