BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OrthoHelix Syndesmosis Fixation Devices

    Reg #: 1649390 · FEI: 3000718467 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TORNIER, INC.
    Registration Number
    1649390
    FEI Number
    3000718467
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10801 Nesbitt Avenue South
    City
    Bloomington
    State
    MN
    ZIP
    55437
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132733

    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
    Washer, Bolt Nut HTN

    Proprietary Names

    OrthoHelix Syndesmosis Fixation Devices

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198