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510(k) Data Aggregation

    K Number
    K180347
    Device Name
    3d Cage
    Manufacturer
    Fims Co., Ltd.
    Date Cleared
    2019-10-28

    (627 days)

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

    Fims Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3d Cage is an intervertebral body fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The device is indicated to be used with a supplemental fixation system and autograft bone.
    Device Description
    3d Cage™ is an intervertebral body fusion cage intended for use in (Posterior/Transforaminal) lumbar spinal fixation procedures. It is an open architecture truss designed to provide effective structural support with open space throughout the implant for bone growth and fusion. The cage is provided sterile and constructed from titanium alloy (Ti-6Al-4V, ASTM F3001) using Selective Laser Melting (SLM) method.
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