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510(k) Data Aggregation

    K Number
    K122850
    Device Name
    TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
    Manufacturer
    MEDITECH ADVISORS, LLC
    Date Cleared
    2013-03-28

    (191 days)

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

    MEDITECH ADVISORS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion, Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.
    Device Description
    Not Found
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    K Number
    K090707
    Device Name
    TALOS INTERVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    MEDITECH ADVISORS, LLC
    Date Cleared
    2009-07-15

    (120 days)

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

    MEDITECH ADVISORS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment. Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
    Device Description
    The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants, to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos™ IBF radiological confirmation for proper positioning.
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