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510(k) Data Aggregation

    K Number
    K012161
    Device Name
    FLEX-NAILS
    Manufacturer
    FIXANO SA
    Date Cleared
    2001-08-24

    (44 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K960385,K983121
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.

    Device Description

    The device is a flexible titanium nail for orthopedic implantation.

    AI/ML Overview

    The provided text is a 510(k) summary for the FLEX-NAILS device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

    This 510(k) summary is a regulatory filing that declares the device sufficiently similar to existing legal devices to be marketed, rather than a detailed report of clinical or performance studies.

    Therefore, I cannot provide the requested information based on the given text.

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