BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Triathlon PSR Tibial Insert

    Reg #: 3013014058 · FEI: 3013014058 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Stryker Anngrove
    Registration Number
    3013014058
    FEI Number
    3013014058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Anngrove Building, IDA Business & Technology Park, Carrigtwohill
    City
    Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K190402

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

    Proprietary Names

    Triathlon PSR Tibial Insert Triathlon Primary Cemented Baseplate (size 0) Triathlon CS Tibial insert (size 0) Triathlon Tritanium Baseplate (size 0) Triathlon CR Tibial Insert (size 0) - Triathlon Pro Instrumentation Triathlon CR Femoral Component (size 0) Triathlon PS Tibial Insert (size 0)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)