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510(k) Data Aggregation

    K Number
    K223140
    Device Name
    AEON-C™ Stand Alone System
    Manufacturer
    Dio Medical Inc
    Date Cleared
    2022-12-20

    (77 days)

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

    Dio Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEON-C™ Stand Alone System is a stand-alone anterior cervical fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral intervertebral fusion device.
    Device Description
    The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.
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