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

    GIBRALT ROD-TO-ROD CROSS CONNECTORS

    K Number: K140645 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    GIBRALT ROD-TO-ROD CROSS CONNECTORS
    K Number
    K140645
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exactech Sarasota
    Date Received
    March 13, 2014
    Decision Date
    April 11, 2014
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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