BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Fixone Meniscal Repair

    K Number: K233601 · Decision Aug 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    2
    Review Days
    267

    Basic Information

    Device Name
    Fixone Meniscal Repair
    K Number
    K233601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aju Pharm Co., Ltd.
    Date Received
    November 9, 2023
    Decision Date
    August 2, 2024
    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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