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510(k) Data Aggregation

    K Number
    K143595
    Date Cleared
    2015-04-29

    (132 days)

    Product Code
    Regulation Number
    888.3080
    Reference & Predicate Devices
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    Device Name :

    NuVasive(R) CCX-L Interbody System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NuVasive CCX-L Interbody System is intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

    The CCX-L Interbody System is intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CCX-L Interbody System. The CCX-L Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

    Device Description

    The CCX-L Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive CCX-L Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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