BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Sterilization change for: AMK (knee), AML (hip), Preservation (knee), Enduron (hip), Hylamer (knee), Duraloc (hip),

    Reg #: 9616671 · FEI: 3002854251 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    DEPUY (IRELAND)
    Registration Number
    9616671
    FEI Number
    3002854251
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOUGHBEG, RINGASKIDDY
    City
    CO. CORK Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K944538

    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, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Sterilization change for: AMK (knee), AML (hip), Preservation (knee), Enduron (hip), Hylamer (knee), Duraloc (hip), Bantam (hip), Endurance (hip), ERS (elbow), Synatomic (knee), Global (shoulder), Self-Centering (hip), ACS (hip)

    Establishment Types

    Manufacture Medical Device