BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Mako Partial Knee

    Reg #: 9616696 · FEI: 3003164255 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Registration Number
    9616696
    FEI Number
    3003164255
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARRIGTWOHILL BUSINESS &, TECHNOLOGY PARK
    City
    CARRIGTWOHILL, CO.CORK Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K172301

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    US Agent

    Business Name
    STRYKER INSTRUMENTS
    Contact Name
    Kim Wiersema
    Address
    1941 Stryker Way, -
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US
    Email
    [email protected]
    Phone
    269 2545351

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Mako Partial Knee

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)