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510(k) Data Aggregation

    K Number
    K200491
    Device Name
    Bfix Orthopedic External Fixator Systems
    Date Cleared
    2021-01-05

    (312 days)

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

    Aike (Shanghai) Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs. The indication for use includes: - open or closed fractures in long bones; - bone defects or reconstructive procedure - limb lengthening
    Device Description
    The Bfix® Orthopedic External Fixator Systems is an external fixation system that consists of various components used for the external stabilization of bone fractures. The external fixators components includes ring, connecting rods, thread rods, posts, couplings, telescopic struts, static struts, washer, clamps and pins that combined to construct different frame configuration which is appropriate for each specification application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.
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