BEUDAMED
    FDA Registration Active 🇫🇷 France

    Aequalis Reversed Shoulder Prosthesis

    Reg #: 3008388276 · FEI: 3008388276 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    TORNIER S.A.S
    Registration Number
    3008388276
    FEI Number
    3008388276
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    176 RUE LAVOISIER
    City
    Montbonnot Saint-Martin Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K151293

    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
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    Aequalis Reversed Shoulder Prosthesis Aequalis Ascend Flex Shoulder System

    Establishment Types

    Manufacture Medical Device