LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K172943
    Device Name
    Flex-Thread Fibula Pin System
    Manufacturer
    IntraFuse LLC
    Date Cleared
    2017-10-30

    (34 days)

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

    IntraFuse LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flex-Thread Fibula Pin System is intended for use in the fixation of fibula fractures and osteotomies.
    Device Description
    The Flex-Thread Fibula Pin 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.
    Ask a Question
    K Number
    K163488
    Device Name
    Flex-Thread Clavicle Pin System
    Manufacturer
    INTRAFUSE LLC
    Date Cleared
    2017-03-20

    (98 days)

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

    INTRAFUSE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
    Device Description
    The Flex-Thread Clavicle Pin System is comprised of an intramedullary fixation device with a flexible threaded distal tip to engage the curved medial portion of a clavicle, and a proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle.
    Ask a Question

    Page 1 of 1