BEUDAMED
    FDA Registration Active 🇨🇳 China

    Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic

    Reg #: 3006356043 · FEI: 3006356043 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
    Registration Number
    3006356043
    FEI Number
    3006356043
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.299, CHANGYANG STREET, SUZHOU INDUSTRIAL PARK
    City
    SUZHOU Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K940743

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    US Agent

    Business Name
    DePuy Synthes
    Contact Name
    Patrick McCullagh
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US
    Email
    [email protected]
    Phone
    267 3005417

    Products

    Device Name Product Code
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Cement Obturator LZN
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB

    Proprietary Names

    Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic Enduron, Hylamer

    Establishment Types

    Manufacture Medical Device