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

    REXIOUS HOOK FIXATION SYSTEMS

    K Number: K113324 · Decision Mar 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    7
    Review Days
    139

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    Basic Information

    Device Name
    REXIOUS HOOK FIXATION SYSTEMS
    K Number
    K113324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dio Medical Co., Ltd.
    Date Received
    November 10, 2011
    Decision Date
    March 28, 2012
    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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