BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Premise Acetabular System

    Reg #: 9616680 · FEI: 3002459190 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    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
    K963612

    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, Cemented JDI
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Premise Acetabular System PCA Acetabular System Osteolock Acetabular System

    Establishment Types

    Manufacture Medical Device