BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇫🇷 France

    SC Medica FFX

    K Number: K232468 · Decision May 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    268

    Basic Information

    Device Name
    SC Medica FFX
    K Number
    K232468
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SC Medica
    Date Received
    August 15, 2023
    Decision Date
    May 9, 2024
    Product Code
    MRW
    Advisory Committee
    Unknown
    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
    MRW System, Facet Screw Spinal Device

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