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510(k) Data Aggregation

    K Number
    K041393
    Manufacturer
    Date Cleared
    2004-08-17

    (85 days)

    Product Code
    Regulation Number
    888.3020
    Reference & Predicate Devices
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    Device Name :

    FASSIER-DUVAL TELSCOPIC IM SYSTEM

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

    This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.

    Device Description

    The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation or a locking pin. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to populate the fields of your request. The document describes a medical device called the "Fassier-Duval Pediatric IM System" and its intended use, but it does not, however, contain any studies, acceptance criteria, or device performance data. Therefore, I cannot generate the table or the additional details about a study.

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