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510(k) Data Aggregation

    K Number
    K141443
    Device Name
    INFRONT LUMBAR INTERBODY FUSION SYSTEM
    Date Cleared
    2014-08-28

    (87 days)

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

    INFRONT MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The InFront Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be use with autograft bone.
    Device Description
    The InFront Lumbar Interbody Fusion System consists of cages of various lengths, widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The InFront Lumbar Interbody Fusion System is to be used with supplemental fixation. The leading edge consists of bullet nose. The cephalad/caudal opening is large to allow for bone through growth. In addition, there are 2 large holes on each side to facilitate bone and to aid in visualizing the fusion mass. The teeth are slanted away from the direction of insertion of the implant to minimize implant migration. The superior and inferior surfaces are convex to better fit the vertebral endplates. The device is offered in 3 general configurations, specifically shaped for posterior, transforaminal or lateral surgical approaches. The posterior approach configuration is available in 508 possible sizes, with lengths from 22mm, widths from 8mm to11mm, heights from 7mm to 16mm and lordosis angles of 0°, 4° and 8°. The transforaminal approach configuration is available in 720 possible sizes, with lengths from 22mm to 36mm, widths from 9mm to 12mm, heights from 7mm to 18mm and lordosis angles of 0°, 4° and 8°. The lateral approach configuration is available in 330 possible sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°. The InFront Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.
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