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510(k) Data Aggregation

    K Number
    K050462
    Device Name
    SBI HAND FIXATION SYSTEM (TM)
    Manufacturer
    SMALL BONE INNOVATIONS LLC
    Date Cleared
    2005-04-26

    (62 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K090522,K101962
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

    Device Description

    The SBI Hand Fixation System™ consists of a series of stainless steel plates and screws of varying lengths and thicknesses and is provided in various configurations, including straight, T-, Y-, Z-, compression L-, compression T-, and compression Y-plates. These plates are attached to bone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tapping cortex screws.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer your questions. The document is a 510(k) summary and the FDA's response letter for the SBI Hand Fixation System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance data or study methodology.

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