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

    FFX Facet Fixation System

    K Number: K252153 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    3
    Review Days
    99

    Basic Information

    Device Name
    FFX Facet Fixation System
    K Number
    K252153
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sc Medica
    Date Received
    July 9, 2025
    Decision Date
    October 16, 2025
    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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    Other Clearances by Sc Medica

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