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510(k) Data Aggregation

    K Number
    K031609
    Device Name
    SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
    Date Cleared
    2003-06-09

    (18 days)

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

    SWISS ORTHOPEDIC SOLUTIONS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.
    Device Description
    The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and screw system. The available plate selection consists of straight, reconstruction, tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm locking screws. The plates in the system can also accept standard spherical 2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate features a hole that is fully threaded, allowing the use of any screw in a variety of positions. The system is available in either stainless steel or titanium.
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