BEUDAMED
    FDA Registration Active 🇨🇳 China

    67210635

    Reg #: 3005323511 · FEI: 3005323511 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    XIAN AIRFOIL TECHNOLOGY CO., LTD.
    Registration Number
    3005323511
    FEI Number
    3005323511
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50Th Building, East hong Qi Road, Xujiawan, Beijiao
    City
    Xian Shaanxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K120578

    Owner / Operator

    Firm Name
    Xian Airfoil Technology Co., Ltd.
    Operator Number
    10043573
    Address
    50Th Building, East hong Qi Road, Xu Jiawan, Beijiao
    City
    Xi'an
    State
    Shaanxi
    Postal Code
    710021
    Country
    CN
    Correspondent
    Zhang Hong

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    67210635 Accolade II Hip Stem 67210435 67200435 67200737 Accolade II Hip Forging Stryker 67200535 67210737 67210330 67200330 67210535 67200635

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)