BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Aequalis" Ascend" Flex Shoulder System

    Reg #: 3008337808 · FEI: 3008337808 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Stryker Macroom
    Registration Number
    3008337808
    FEI Number
    3008337808
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hartnetts Cross, Macroom
    City
    Co Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K190521

    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, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Aequalis" Ascend" Flex Shoulder System Tornier Flex Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)