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510(k) Data Aggregation

    K Number
    K233873
    Device Name
    XLO Brand of Locking Distal Humerus Plating System
    Date Cleared
    2024-04-26

    (141 days)

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

    Ortho Life Systems Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. The system is indicated for use in adult patients only. All implants are for single use only.
    Device Description
    The XLO Brand of Locking Distal Humerus Plating System consists of various shape and sizes of plates featuring compression and locking or non-locking holes, full threaded-cortical, locking or non-locking & self-tapping screws. The XLO Brand of Locking Distal Humerus Plating System consists of the following implants: - Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, Left & Right - Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, With Lateral Support Left & Right - 3.5mm cortical screw - 2.7mm locking screw - 3.5mm locking screw The aforementioned plates are used with cortical screws & locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy. The plates and screws are fabricated from titanium-alloy (Ti-6Al-4V). These implants are sold non-sterile, the products have to be sterilized prior to use.
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