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510(k) Data Aggregation

    K Number
    K230614
    Device Name
    Cortium™
    Manufacturer
    ulrich medical USA
    Date Cleared
    2023-05-02

    (57 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K161032,K994187,K150650,K113346
    Why did this record match?
    Device Name :

    Cortium™

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cortium is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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.

    Cortium is also intended to restore the integrity of the spinal column even 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for use.

    Device Description

    The Cortium system is a posterior occipital-cervical-thoracic (OCT) spinal fixation system. The system components include longitudinal rods, screw anchors, and interconnecting devices such as anchor-to-rod and rod-to-rod connectors, rod-to-rod crosslinks and screw-to-screw crosslinks.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about an AI/ML-driven device, its acceptance criteria, or a study proving that it meets those criteria.

    The document is a 510(k) premarket notification for a medical device called "Cortium™," which is a Posterior Cervical Screw System (an orthopedic implant). The performance data section refers to mechanical testing of the implant's constructs, not a study of an AI/ML algorithm.

    Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a corresponding study from this text.

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