LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972217
    Device Name
    ORTHOPEDIC SCREW SYSTEM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-11-20

    (161 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K792022,K792291,K921622,K924018,K931524,K940207,K960537,K961234,K962011
    Why did this record match?
    Device Name :

    ORTHOPEDIC SCREW SYSTEM

    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 screws.

    AI/ML Overview

    The provided text is related to a 510(k) submission for an "Orthopedic Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, along with the FDA's decision. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be typically found in a clinical study report or a summary of safety and effectiveness data.

    Therefore, I cannot extract the requested information from the provided input. The document is primarily a regulatory clearance letter, not a performance study report.

    If you have a document that details the performance study, please provide it, and I will do my best to answer your questions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1