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

    INSTINCT JAVA SYSTEM

    K Number: K122592 · Decision Jan 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    5
    Review Days
    133

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    Basic Information

    Device Name
    INSTINCT JAVA SYSTEM
    K Number
    K122592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Spine
    Date Received
    August 24, 2012
    Decision Date
    January 4, 2013
    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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    Other Clearances by Zimmer Spine

    K Number Device Name
    K123552 INSTINCT JAVA SYSTEM
    K113270 INSTINCT JAVA SYSTEM
    K111301 INSTINCT JAVA SYSTEM
    K110348 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM