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510(k) Data Aggregation

    K Number
    K080058
    Device Name
    TURBO PRIME IBD SYSTEM
    Manufacturer
    SPINE SELECT, LLC
    Date Cleared
    2008-04-16

    (98 days)

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

    SPINE SELECT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Turbo Prime IBD (Interbody Device) 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 who have had at least six months of non-operative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
    Device Description
    The Turbo Prime IBD System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).
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