BEUDAMED
    FDA Registration Active 🇫🇷 France

    Aequalis Ascend FLEX Shoulder System

    Reg #: 3000931034 · FEI: 3000931034 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Tornier S.A.S.
    Registration Number
    3000931034
    FEI Number
    3000931034
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    161 rue Lavoisier
    City
    Montbonnot Saint-Martin Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K122698

    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, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Aequalis Ascend FLEX Shoulder System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198