BEUDAMED
    FDA 510(k) FDA unclassified Unknown 🇺🇸 United States

    PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER

    K Number: K090767 · Decision Jun 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    70
    Applicant Total
    8
    Review Days
    80

    Basic Information

    Device Name
    PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
    K Number
    K090767
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    INTERVENTIONAL SPINE, INC.
    Date Received
    March 23, 2009
    Decision Date
    June 11, 2009
    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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