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510(k) Data Aggregation

    K Number
    K040272
    Manufacturer
    Date Cleared
    2004-02-23

    (18 days)

    Product Code
    Regulation Number
    872.4760
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) CRANIOFACIAL PLATES

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

    The Synthes Craniofacial 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 Double Adaption Plate can be cut or trimmed to the desired length to accommodate various fractures and meet the anatomical need of the patient. The plate has a low plate / screw head profile, uses 2.0 mm self-tapping or self-drilling bone screws and 2.4 mm emergency screws.

    AI/ML Overview

    I'm sorry, but based on the provided text, there is no information about acceptance criteria, device performance testing, or any studies involving AI or human readers. The document is a 510(k) summary for a medical device (Craniofacial Plates) and primarily discusses regulatory aspects, intended use, and substantial equivalence to a predicate device. It does not contain the details required to answer your request.

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