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510(k) Data Aggregation

    K Number
    K151580
    Device Name
    D.N.E. External Fixation System
    Manufacturer
    Date Cleared
    2016-02-16

    (250 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DNE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonumions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
    Device Description
    The D.N.E. External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints. An Angular Correction Clamp and associated Struts have been added to the system in order to facilitate a surgeons ability to step down in ring sizes.
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