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

    PREFERENCE PEDICLE SCREW SYSTEM

    K Number: K081296 · Decision Jun 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    PREFERENCE PEDICLE SCREW SYSTEM
    K Number
    K081296
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Us Spine
    Date Received
    May 7, 2008
    Decision Date
    June 6, 2008
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Us Spine

    K Number Device Name
    K082801 PHANTOM PLUS CAGE SYSTEM
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    K061041 US SPINE FACET FIXATION SYSTEM