BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    MODIFICATION TO: DSS STABILIZATION SYSTEM

    K Number: K090408 · Decision Mar 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    11
    Review Days
    30

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    Basic Information

    Device Name
    MODIFICATION TO: DSS STABILIZATION SYSTEM
    K Number
    K090408
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Paradigm Spine, LLC
    Date Received
    February 18, 2009
    Decision Date
    March 20, 2009
    Product Code
    NKB
    Advisory Committee
    Orthopedic
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    K101083 DSS STABILIZATION SYSTEM
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