BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ReUnion RSA. ReUnion RFX, ReUnion TSA

    Reg #: 8031020 · FEI: 3002807830 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    STRYKER GmbH
    Registration Number
    8031020
    FEI Number
    3002807830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BOHNACKERWEG 1
    City
    SELZACH Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K161863

    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
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    ReUnion RSA. ReUnion RFX, ReUnion TSA

    Establishment Types

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