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510(k) Data Aggregation

    K Number
    K152370
    Device Name
    PRECICE Trauma Nail System
    Date Cleared
    2015-12-22

    (123 days)

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

    Ellipse Technologies Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
    Device Description
    The PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC or ERC 2P). The Nail is available in various diameters, lengths and screw-hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model) to allow for compression fracture reduction techniques.
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