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510(k) Data Aggregation

    K Number
    K093928
    Manufacturer
    Date Cleared
    2010-03-29

    (97 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

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

    Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.

    Device Description

    Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in short, standard, and long versions

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a medical device (Synthes 3.5mm Quadrilateral Surface Plates).

    It includes information such as:

    • Sponsor and device name
    • Classification and predicate device
    • Device description and indications for use
    • A determination of substantial equivalence by the FDA

    However, it does not detail:

    • Specific acceptance criteria (e.g., performance metrics, thresholds)
    • Any study design, test set characteristics, expert qualifications, adjudication methods, or results of performance testing that would demonstrate conformance to such criteria.

    Therefore, I cannot fulfill your request for the table and study details based on the given input.

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