BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Gamma4 System

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

    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
    K222309

    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
    Rod, Fixation, Intramedullary And Accessories HSB

    Proprietary Names

    Gamma4 System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device