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

    CERVICAL CAGE

    K Number: K110915 · Decision Jul 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    8
    Review Days
    112

    Basic Information

    Device Name
    CERVICAL CAGE
    K Number
    K110915
    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
    April 1, 2011
    Decision Date
    July 22, 2011
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Eisertech, LLC

    K Number Device Name
    K192768 Temporary Fixation Pins
    K190565 Cervical Plate
    K140348 INTERBODY CAGE
    K142576 Spinal System
    K122444 CERVICAL CAGE
    K113170 CERVICAL PLATE
    K113478 PLIF CAGE