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510(k) Data Aggregation

    K Number
    K241983
    Device Name
    Fassier-Duval Telescoping IM System
    Manufacturer
    Orthopediatrics Canada ULC dba Pega Medical
    Date Cleared
    2025-02-21

    (228 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orthopediatrics Canada ULC dba Pega Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta and other pediatric bone diseases without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.
    Device Description
    The Fassier-Duval Telescopic 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. The naliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates. The device is sold both sterile and Non sterile.
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