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510(k) Data Aggregation

    K Number
    K202326
    Device Name
    BESPA Charcot System
    Manufacturer
    Date Cleared
    2021-11-09

    (449 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bespa Global, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations. The device is for prescription use only.
    Device Description
    The BESPA Charcot System is offered non-sterile and consists of implants and system-specific instruments. The Segmental Column is composed of various modular cylindrical components which screw together to create an implant assembly of the surgeon's desired features. The system contains transverse screws of various lengths. The implant construct has a compression capability. All implants are made of titanium alloy.
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