BEUDAMED
    FDA Registration Active 🇨🇳 China

    DEPUY SIGMA XLK TIBIAL INSERTS

    Reg #: 3004748528 · FEI: 3004748528 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Registration Number
    3004748528
    FEI Number
    3004748528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K040166

    Owner / Operator

    Firm Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Operator Number
    9066119
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    State
    CN-NOTA
    Postal Code
    201707
    Country
    CN

    US Agent

    Business Name
    MANTON BUSINESS & TECHNOLOGY SERVICES, LLC
    Contact Name
    Charles Shen
    Address
    37 Winding Rdg
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    608 2179358

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    DEPUY SIGMA XLK TIBIAL INSERTS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)