Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K093753
    Device Name
    MDPO FRAME SYSTEM
    Manufacturer
    Date Cleared
    2010-08-26

    (262 days)

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

    MDPO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MDPO Frame System is indicated for use in the lower extremity for: open and closed long bone fracture fixation, to include tensioned wire fixation of periarticular fractures, arthrodesis, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities, dislocations, arthrodiastasis, and Charcot foot reconstruction and Lisfranc dislocations.
    Device Description
    The MDPO Frame System is an external fixation system that can be made into various configurations for lower limb application. The MDPO Frame System includes the following components: Half Pins, Wires, Footplate consisting of the Connecting Plate/Assembly with interchanging Medial and Lateral Arch Plates/Assemblies, Matching Rings, Open Rings, Closed Circular Rings, Columns, Threaded Rods, Sockets, Screws, Bolts, Nuts, Washers, Posts, and Cubes. The components of the MDPO Frame System are made from stainless steel, carbon fiber, Radel or aluminum. All components are designed for single use only.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1