BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CalcLock

    Reg #: 3004983210 · FEI: 3004983210 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TORNIER Inc.
    Registration Number
    3004983210
    FEI Number
    3004983210
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4375 E. Park 30 Drive
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061400

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    CalcLock Calcaneal Trauma System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility