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

    PLIF CAGE

    K Number: K113478 · Decision Mar 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    422
    Registration Numbers
    422
    Same Product Code
    869
    Applicant Total
    6
    Review Days
    103

    Basic Information

    Device Name
    PLIF CAGE
    K Number
    K113478
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EISERTECH, LLC
    Date Received
    November 23, 2011
    Decision Date
    March 5, 2012
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by EISERTECH, LLC

    K Number Device Name
    K140348 INTERBODY CAGE
    K142576 Spinal System
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    K110915 CERVICAL CAGE