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

    SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT

    K Number: K082795 · Decision Dec 12, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    77
    Applicant Total
    8
    Review Days
    80

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    Basic Information

    Device Name
    SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
    K Number
    K082795
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interventional Spine, Inc.
    Date Received
    September 23, 2008
    Decision Date
    December 12, 2008
    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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