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510(k) Data Aggregation

    K Number
    K162003
    Device Name
    IMSE Cervical Cage
    Date Cleared
    2016-12-21

    (154 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    **The Institute of Musculoskeletal Science **& Education

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.
    Device Description
    The IMSE Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The IMSE Cervical Cage of intervertebral body fusion devices are made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
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