Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203381
    Device Name
    Dynanail Mini Hybrid
    Manufacturer
    MedShape Inc
    Date Cleared
    2021-01-15

    (59 days)

    Product Code
    HWC, JDS
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedShape Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.
    Device Description
    The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
    Ask a Question

    Page 1 of 1