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510(k) Data Aggregation

    K Number
    K091493
    Device Name
    ORTHO SELECT BONE PLATES AND SCREW SYSTEM
    Manufacturer
    ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT
    Date Cleared
    2010-02-05

    (261 days)

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

    ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis. In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.
    Device Description
    The ORTHO SELECT Bone Plates and Screw System consists of stainless steel bone plate and bone screw implants intended for internal fixation of pelvic, small and long bone fractures according to the standard of the AO Foundation (AO Principles of Fracture Management). The bone plates and screws are provided non-sterile for steam sterilization by user and single use only.
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