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510(k) Data Aggregation

    K Number
    K111484
    Device Name
    DISCOVERY
    Manufacturer
    INTUITIVE SPINE, LLC
    Date Cleared
    2011-09-12

    (104 days)

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

    INTUITIVE SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
    Device Description
    The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.
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