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510(k) Data Aggregation

    K Number
    K113384
    Manufacturer
    Date Cleared
    2012-05-01

    (167 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Citieffe External Fixator ST.A.R. 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include: - Fracture dislocation with ligaments instability; - Comminuted intra-articular fractures; l - Post traumatic reconstruction for joint stiffness. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

    Citieffe External Fixator ST.A.R. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. All blanks are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a medical device (ST.A.R. 90 F4 External Fixator) and outlines its intended use. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval and indications for use, not performance studies or acceptance criteria.

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