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510(k) Data Aggregation

    K Number
    K252737
    Manufacturer
    Date Cleared
    2025-10-10

    (43 days)

    Product Code
    Regulation Number
    888.3080
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Latitude-C AM™ Interbody Spacer is indicated for spinal fusion procedures at one or more levels in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

    The Latitude-C AM™ Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Cyclops™ Anterior Cervical Plate System.

    Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C AM™ Interbody Spacer in the cervical spine.

    Device Description

    The DeGen Medical Latitude-C AM™ Cervical Interbody Fusion System is an additively manufactured anterior cervical interbody fusion system for anterior cervical fusion procedures. Latitude-C AM™ cervical spacers are comprised of a single component that is additively manufactured. Latitude-C AM™ spacers are available in the following configurations; lordotic, anatomic, and symmetric. The superior and inferior sides of the endplates of the spacer feature porous surfaces to facilitate fusion and mitigate subsidence and expulsion and feature a central aperture to constrain bone graft. Latitude-C AM™ spacers include various depths, widths, heights, and angles of lordosis. Latitude-C AM™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium.

    AI/ML Overview

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