Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964087
    Device Name
    BLOCK STOP WIRES
    Manufacturer
    Date Cleared
    1996-11-25

    (45 days)

    Product Code
    Regulation Number
    888.3040
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.

    Device Description

    The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.

    AI/ML Overview

    I apologize, but the provided text from the document "K964087" is a 510(k) summary for a medical device called "Block Stop Wires." It describes the classification, substantial equivalence, device description, intended use, and technological characteristics of the device.

    However, the document does not contain any information regarding acceptance criteria, device performance study results, sample sizes, expert qualifications, ground truth, or adjudication methods. Therefore, I cannot generate the requested table or answer your specific questions based on the input provided.

    To answer your questions, I would need a document that details the device's validation studies and performance evaluation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1