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510(k) Data Aggregation

    K Number
    K110733
    Device Name
    DAYTONA ANTERIOR CERVICAL CAGE
    Manufacturer
    SPINENET, LLC
    Date Cleared
    2011-08-25

    (162 days)

    Product Code
    ODP
    Regulation Number
    888.3080
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    Applicant Name (Manufacturer) :

    SPINENET, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The Daytona Anterior Cervical Cage system was developed as an intracorporeal implant for anterior cervical spondylodesis. The Daytona Anterior Cervical Cage is a system of wedge shaped implants and instruments designed for anterior cervical interbody fusion (ACIF). To prevent migration, the Daytona Anterior Cervical Cage has teeth on its superior and inferior surfaces.
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