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

    Internal Joint Stabilizer - Elbow

    K Number: K223318 · Decision May 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    11
    Review Days
    194

    Basic Information

    Device Name
    Internal Joint Stabilizer - Elbow
    K Number
    K223318
    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, Inc.
    Date Received
    October 28, 2022
    Decision Date
    May 10, 2023
    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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