BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    S-ROM™ NOILES™ Rotating Hinge Knee System

    Reg #: 3015516266 · FEI: 3015516266 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Depuy Ireland UC
    Registration Number
    3015516266
    FEI Number
    3015516266
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Loughbeg, Ringaskiddy
    City
    Co. Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K241000

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

    Proprietary Names

    S-ROM™ NOILES™ Rotating Hinge Knee System DePuy SIGMA™ Total Knee Prosthesis DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components DePuy P.F.C. ™ SIGMA™ Total Knee Prosthesis ATTUNE™ Revision Knee System DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device