BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Polymer Implant

    Reg #: 2249697 · FEI: 3003070421 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HOWMEDICA OSTEONICS CORP
    Registration Number
    2249697
    FEI Number
    3003070421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    325 CORPORATE DR.
    City
    MAHWAH
    State
    NJ
    ZIP
    07430
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103010

    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
    Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
    Plate, Cranioplasty, Preformed, Alterable GWO

    Proprietary Names

    Polymer Implant

    Establishment Types

    Manufacture Medical Device