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

    INTEGRA FACET FIXATION SYSTEM

    K Number: K132859 · Decision Nov 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    27
    Review Days
    67

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    Basic Information

    Device Name
    INTEGRA FACET FIXATION SYSTEM
    K Number
    K132859
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seaspine, Inc.
    Date Received
    September 12, 2013
    Decision Date
    November 18, 2013
    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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