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    K Number
    K221021
    Device Name
    Femoral Trochanteric Nail System – Neonail
    Manufacturer
    Neoortho Produtos Ortopédicos S/A
    Date Cleared
    2022-12-06

    (244 days)

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

    Neoortho Produtos Ortopédicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Femoral Trochanteric Nail System - Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur.
    Device Description
    An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Femoral Trochanteric Nail System – Neonail consists of metal rods, bone screws, and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.
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