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

    OAKTREE Anterior Lumbar Plate and Screw System

    K Number: K220843 · Decision Dec 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    2
    Review Days
    259

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    Basic Information

    Device Name
    OAKTREE Anterior Lumbar Plate and Screw System
    K Number
    K220843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oak Tree Engineering, LLC
    Date Received
    March 23, 2022
    Decision Date
    December 7, 2022
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

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    Other Clearances by Oak Tree Engineering, LLC

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