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510(k) Data Aggregation

    K Number
    K140158
    Device Name
    S.E.A.L. FRACTURE FUSION TUBE
    Manufacturer
    Date Cleared
    2014-05-29

    (127 days)

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

    D.N.E., LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
    Device Description
    The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
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    K Number
    K113106
    Device Name
    DNE EXTERNAL FIXATION SYSTEM
    Manufacturer
    Date Cleared
    2012-01-04

    (76 days)

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

    D.N.E., LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
    Device Description
    The DNE 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. Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
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