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510(k) Data Aggregation

    K Number
    K123745
    Device Name
    SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
    Date Cleared
    2013-03-25

    (109 days)

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

    BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following: - Open and closed femoral fractures . - Pseudoarthrosis and correction osteotomy . - Pathologic fractures, including those with intra-articular extension . - Ipsilateral femur fractures . - Fractures proximal to a total knee arthroplasty . - Fractures distal to the hip ioint ● - Nonunions and malunions . The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following: - Open or closed shaft fractures with a very proximal and very distal . extent in which locking screw fixation can be obtained - Pseudarthrosis . - Pathologic and impending pathologic fractures . - Multi-fragment fractures . - Segmental fractures . - . Proximal or distal non-unions - . Corrective osteotomies - Tumor resections - . Comminuted fractures with or without bone loss
    Device Description
    The Biomecanica SP2 Femoral Locking Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Biomecanica SP2 Femoral Locking Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Biomecanica SP2 Femoral Locking Nail is currently available in diameters ranging from 9 to 12 mm and lengths ranging from 180 to 460 mm. The Biomecanica SP2 Tibial Locking Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilizations of the tibia. The intramedullary nails are available in diameter ranging from 9 to 11mm and lengths ranging from 200 to 440mm. Each of the nails is secured by a series of screws that pass through holds manufactured into the proximal and distal sections of each nail. All components of the SP2 Femoral and Tibial Locking Nails are made of titanium alloy.
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