BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEEDLE GUIDE

    Reg #: 1649390 · FEI: 3000718467 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    25
    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

    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
    Guide, Surgical, Instrument FZX

    Proprietary Names

    NEEDLE GUIDE ANTEVERSION GUIDE WIRE AND DRILL GUIDE DRILL GUIDE STERNUM SAW REPLACEMENT GUIDE OSTEONICS RESECTION GUIDE DRILL SLEEVE FUNNEL Cut Guide Drill Guide Non Sterile Instrument Guides VariAx 2, K-Wire Tornier Extraction VariAx 2, Drill Guide T2 Guide Wire Ball Tip VariAx 2 Foot, SpeedGuide Knotilus+ Crown Tip Guide, Hip Knotilus+ Crown Tip Guide VariAx 2, K-Wire with Olive Stop VariAx Foot, K-Wire VariAx 2, SpeedGuide Knotilus+ Offset Tip Guide Knotilus+ Fishmouth Tip Guide Knotilus+ Fork Tip Guide, Hip

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198