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510(k) Data Aggregation

    K Number
    K203408
    Device Name
    Summit Patella Plating System
    Date Cleared
    2021-07-30

    (253 days)

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

    Endeavor Orthopaedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Summit Patella Plating System is indicated for use in surgical stabilization of patella fractures during open reduction internal fixation (ORIF) procedures in adults. Each system includes a plate, screws, surgical suture, and instruments that are provided in a sterile procedure kit and intended for single use.
    Device Description
    The Endeavor Orthopaedics Summit Patella Plating System is a plating system used for fixation of patella fractures. The system includes implants and ancillary instruments needed for open reduction internal fixation (ORIF) of a patella fracture, packaged together in a single use sterile procedure kit. The kit provides a patella plate, locking screws, nonabsorbable sutures with needles and surgical instrumentation required for preparation of fracture fragments, manipulation/reduction of the patella, provisional fixation, plate placement and definitive fixation to the dorsal surface of the patella. The system is intended for single use, by a licensed orthopedic surgeon.
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