BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TPS Console

    Reg #: 3007997036 · FEI: 3007997036 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    7

    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
    K032117

    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
    Unit, Operative Dental EIA
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Motor, Surgical Instrument, Ac-Powered GEY
    Drill, Bone, Powered DZI
    Motor, Drill, Electric HBC
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    TPS Console TPS Micro Drill/Elite Attachment Brush TPS Standard Attachment Brush TPS Unidirectional Footswitch

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)