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

    VENUS FACET SCREW SYSTEM

    K Number: K120340 · Decision Oct 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    VENUS FACET SCREW SYSTEM
    K Number
    K120340
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apollo Spine, Inc.
    Date Received
    February 3, 2012
    Decision Date
    October 19, 2012
    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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