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510(k) Data Aggregation

    K Number
    K033121
    Device Name
    1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2003-10-20

    (20 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K102656,K192655,K192702
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synthes 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    Device Description

    The Synthes 1.3 & 1.5mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and for single use only.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The text is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.3 & 1.5mm Contourable Titanium Mesh Plates). This type of document primarily focuses on establishing substantial equivalence to a predicate device, not on specific performance acceptance criteria or detailed study results demonstrating the device meets those criteria.

    Therefore, I cannot provide a response to your request as the information is not present in the given document.

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