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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Button Loop

    K Number: K202291 · Decision Jan 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    2
    Review Days
    149

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    Basic Information

    Device Name
    Button Loop
    K Number
    K202291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yunyi (Beijing) Medical Device Co., Ltd.
    Date Received
    August 12, 2020
    Decision Date
    January 8, 2021
    Product Code
    MBI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Yunyi (Beijing) Medical Device Co., Ltd.

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