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

    AQUA Laminoplasty Systems

    K Number: K252930 · Decision May 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    29
    Applicant Total
    11
    Review Days
    254

    Basic Information

    Device Name
    AQUA Laminoplasty Systems
    K Number
    K252930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZheJiang Decans Medical Devices Co., Ltd.
    Date Received
    September 15, 2025
    Decision Date
    May 27, 2026
    Product Code
    NQW
    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
    NQW Orthosis, Spine, Plate, Laminoplasty, Metal

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