BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Hoffmann 3 Modular External Fixation System

    Reg #: 3031800723 · FEI: 3031800723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Stryker Poland Manufacturing Sp. z o.o.
    Registration Number
    3031800723
    FEI Number
    3031800723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pulkownika Andrzeja Halacinskiego 1
    City
    Skawina Malopolskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K121252

    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 CORP.
    Contact Name
    Shamaila Rafiq
    Address
    2 Pearl Ct
    City
    Allendale
    State
    NJ
    ZIP
    07401
    Country
    US
    Email
    [email protected]
    Phone
    201 3769049

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Hoffmann 3 Modular External Fixation System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)