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

    US SPINE FACET FIXATION SYSTEM

    K Number: K061041 · Decision Jun 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    US SPINE FACET FIXATION SYSTEM
    K Number
    K061041
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Us Spine
    Date Received
    April 14, 2006
    Decision Date
    June 19, 2006
    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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