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

    ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM

    K Number: K141123 · Decision Feb 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    10
    Review Days
    302

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    Basic Information

    Device Name
    ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
    K Number
    K141123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Partners, LLC
    Date Received
    May 1, 2014
    Decision Date
    February 27, 2015
    Product Code
    GWO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWO Plate, Cranioplasty, Preformed, Alterable

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