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510(k) Data Aggregation

    K Number
    K153370
    Device Name
    Caspian OCT/MESA Mini/DENALI Mini Spinal System
    Manufacturer
    K2M, Incorporated
    Date Cleared
    2016-02-16

    (85 days)

    Product Code
    NKG,KWP
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K150474,K081107,K133288,K152338,K151755,K151885,K150552
    Predicate For
    K171444,K181603,K182182,K233989
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the integrity of the spinal column eyen in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.

    Device Description

    The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add modified plates and rods and to revise the Indications for Use.

    AI/ML Overview

    The provided text is an FDA 510(k) Premarket Notification for a spinal system, not a study evaluating an AI/CADe medical device. Therefore, it does not contain the information required to answer your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/CADe performance, ground truth, sample sizes, or expert adjudication.

    The document describes a spinal fixation system, its indications for use, and a comparison to predicate devices, focusing on mechanical testing and material equivalence rather than diagnostic performance metrics.

    To answer your prompt, I would need a different type of document, such as a clinical study report or a 510(k) submission for an AI/CADe device that details its performance evaluation.

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