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510(k) Data Aggregation

    K Number
    K071479
    Device Name
    SBI STAFIX
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Date Cleared
    2007-08-02

    (65 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SBI STAFIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBi StaFIX is indicated for: . Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones. . Fixation of soft tissue to bone

    Device Description

    The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes.

    AI/ML Overview

    The provided text is a 510(k) summary for the SBi StaFIX bone fixation system, a medical device. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices.

    However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It is a regulatory filing for market clearance based on substantial equivalence, not a detailed technical performance study report. Therefore, I cannot extract the requested information from the provided text.

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