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510(k) Data Aggregation

    K Number
    K202858
    Device Name
    Flex-ThreadTM Distal Fibula Intramedullary Nail System
    Manufacturer
    Conventus Orthopaedics, LLC
    Date Cleared
    2021-01-22

    (116 days)

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

    Conventus Orthopaedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.
    Device Description
    The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.
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