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

    ADI TiDAL Osteotomy Wedge

    K Number: K191047 · Decision Nov 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    200

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    Basic Information

    Device Name
    ADI TiDAL Osteotomy Wedge
    K Number
    K191047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Additive Device, Inc. (Adi) D/B/A Restor3D
    Date Received
    April 19, 2019
    Decision Date
    November 5, 2019
    Product Code
    PLF
    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
    PLF Bone Wedge

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