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

    ABBOTT SPINE UNIVERSAL CLAMP SYSTEM

    K Number: K060009 · Decision Mar 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    13
    Review Days
    62

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    Basic Information

    Device Name
    ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
    K Number
    K060009
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Spine, Inc.
    Date Received
    January 3, 2006
    Decision Date
    March 6, 2006
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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