BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACM system with cancellous

    Reg #: 3015967359 · FEI: 3015967359 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Stryker Instruments
    Registration Number
    3015967359
    FEI Number
    3015967359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1941 Stryker Way
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Regulatory Submissions

    510(k) Number
    K955599

    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
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Cement Obturator LZN

    Proprietary Names

    ACM system with cancellous STAINLESS STEEL INSERTER FEMORAL SPONGE PKG 6

    Establishment Types

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