BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rotating Footed Attachment 16mm

    Reg #: 3007997036 · FEI: 3007997036 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STRYKER MANUFACTURING KALAMAZOO
    Registration Number
    3007997036
    FEI Number
    3007997036
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6201 South Sprinkle Road
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191049

    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
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    Rotating Footed Attachment 16mm MIS 13 cm Straight Nose Tube MIS 13 cm Modified Curved Nose Tube Footed Attachment 16mm Footed Attachment 25mm Footed Attachment 12mm MIS 16 cm Straight Nose Tube Non-Footed Attachment 9cm MIS 13 cm Straight Hooded Nose Tube Non-Footed Attachment 8cm MIS 13 cm Curved Nose Tube MIS 16 cm Straight Hooded Nose Tube MIS 16 cm Curved Nose Tube Rotating Footed Attachment 12mm MIS 16 cm Angled Nose Tube MIS 13 cm Angled Nose Tube Rotating Footed Attachment 25mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)