BEUDAMED
    FDA Registration Active 🇨🇳 China

    Genesis II oval resurfacing patellar trial

    Reg #: 3011295718 · FEI: 3011295718 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Suzhou Elite Precision Machinery Co., Ltd.
    Registration Number
    3011295718
    FEI Number
    3011295718
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.498 Fengxing Rd, Huaqiao Town
    City
    Kunshan Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150241

    Owner / Operator

    Firm Name
    Suzhou Elite Precision Machinery Co., Ltd.
    Operator Number
    10048840
    Address
    No.498 Fengxing Rd, Huaqiao Town
    City
    Kunshan
    State
    Jiangsu
    Postal Code
    215332
    Country
    CN

    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, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    Genesis II oval resurfacing patellar trial

    Establishment Types

    Manufacture Medical Device