LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972219
    Device Name
    ORTHOPEDIC PLATE SYSTEM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-11-20

    (161 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K770128,K782123,K792291,K862224,K864924,K890641,K903252,K912936,K914803,K921338,K922167,K923861,K924085,K930480,K930592,K930966,K931687,K933112,K953644
    Predicate For
    K022139
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.

    Device Description

    The device is an assortment of various sizes and configurations of stainless steel bone plates.

    AI/ML Overview

    I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for an "Orthopedic Plate System." This document primarily focuses on establishing "substantial equivalence" to previously marketed devices rather than detailing specific performance acceptance criteria or a dedicated study proving performance against such criteria.

    Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies from the given text.

    The document states:

    • The device is an assortment of various sizes and configurations of stainless steel bone plates.
    • The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
    • The Orthopedic Plate System is a standardly used device.
    • The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets the same general safety and effectiveness standards as those products.

    To provide the requested information, a different type of document, such as a clinical study report, a scientific publication, or a more detailed technical file, would be needed.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1