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510(k) Data Aggregation

    K Number
    K113387
    Device Name
    CITIEFFE TITANIUM NAILING SYSTEM
    Manufacturer
    CITIEFFE
    Date Cleared
    2012-03-15

    (120 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Citieffe Titanium Nailing System is intended for insertion into the medullary canal of a specific long bone – humerus and femur -for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

    Device Description

    Citieffe Titanium Nailing System

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter for the Citieffe Titanium Nailing System. It focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies or acceptance criteria of an AI or software device.

    Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for a device performance study cannot be extracted from this document. This document is not a study report.

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