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

    EMERALD SPINAL SYSTEM

    K Number: K101446 · Decision Jan 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    7
    Review Days
    241

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    Basic Information

    Device Name
    EMERALD SPINAL SYSTEM
    K Number
    K101446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mazor Surgical Technologies , Ltd.
    Date Received
    May 24, 2010
    Decision Date
    January 20, 2011
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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