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510(k) Data Aggregation

    K Number
    K063181
    Device Name
    SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2007-01-05

    (78 days)

    Product Code
    NEI
    Regulation Number
    872.4770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K990637,K020199
    Predicate For
    K183113
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

    Device Description

    The Synthes (USA) Condylar Head Add-on System is an adjustable height system intended for use with Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Synthes (USA) Condylar Head Add-on System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than performance studies or clinical trials.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the given information.

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