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    K Number
    K081700
    Device Name
    SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2008-07-17

    (30 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION

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

    The Synthes (USA) Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

    Device Description

    The Synthes (USA) Sternal Fixation System consists of machined titanium plates, a quick-release pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, a study, sample sizes, experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, or ground truth.

    The document is a 510(k) summary and an FDA clearance letter for the Synthes (USA) Sternal Fixation System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the detailed study design and results typically found in a clinical trial report.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance.

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