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

    MYKRES SPINAL SYSTEM

    K Number: K051704 · Decision Jul 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    302
    Applicant Total
    2
    Review Days
    374

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    Basic Information

    Device Name
    MYKRES SPINAL SYSTEM
    K Number
    K051704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Showa Ika Kohgyo Co., Ltd.
    Date Received
    June 24, 2005
    Decision Date
    July 3, 2006
    Product Code
    MNI
    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
    MNI Orthosis, Spinal Pedicle Fixation

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    Other Clearances by Showa Ika Kohgyo Co., Ltd.

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