BEUDAMED
    FDA Registration Active 🇫🇷 France

    Aequalis Shoulder System - glenoid

    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
    K994392

    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 Shoulder System - glenoid

    Establishment Types

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