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510(k) Data Aggregation

    K Number
    K111512
    Device Name
    BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
    Manufacturer
    THOMPSON MIS INC
    Date Cleared
    2011-10-26

    (147 days)

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

    THOMPSON MIS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
    Device Description
    The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.
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