BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    System 12 Acetabular System

    Reg #: 9616680 · FEI: 3002459190 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    STRYKER IRELAND OSTEONICS
    Registration Number
    9616680
    FEI Number
    3002459190
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tullagreen Building, IDA Business & Technology Park, Carrigtwohill
    City
    Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K964655

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    System 12 Acetabular System Unitrax Centrax Duracon Knee System Kinemax Plus Knee System PCA Acetabular System Premise Acetabular System PCA Knee System Osteocolock Acetabular System

    Establishment Types

    Manufacture Medical Device