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510(k) Data Aggregation

    K Number
    K063506
    Device Name
    LORENZ STERNAL CLOSURE SYSTEM
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    2006-12-18

    (28 days)

    Product Code
    HRS,87H
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011076,K033740,K013954,K032228
    Predicate For
    K110039,K110574,K111908
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

    Device Description

    The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to 16mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. The Lorenz Sternal Closure System will be marketed as non-sterile, single use devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or details about ground truth establishment. The document is a 510(k) summary for the Lorenz Sternal Closure System, primarily focusing on its intended use, description, materials, sterility, and substantial equivalence to previously cleared devices. It also lists possible risks associated with the device.

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

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