BEUDAMED
    FDA Registration Active 🇫🇷 France

    Navigation Enabled (Xia 2, Xia 3, Xia 4.5, ES2, Mantis)

    Reg #: 9617544 · FEI: 3003112432 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER SPINE
    Registration Number
    9617544
    FEI Number
    3003112432
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZONE INDUSTRIELLE DE MARTICOT
    City
    CESTAS Nouvelle-Aquitaine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K183381

    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
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Navigation Enabled (Xia 2, Xia 3, Xia 4.5, ES2, Mantis)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)