BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Modular Rail System

    Reg #: 3007366790 · FEI: 3007282753 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Smith & Nephew, Inc.
    Registration Number
    3007366790
    FEI Number
    3007282753
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3303 E Holmes Rd
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201253

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Software For Diagnosis/Treatment OSN
    Pin, Fixation, Threaded JDW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    Modular Rail System ILIZAROV External Fixator JET-X Fixator TAYLOR SPATIAL FRAME External Fixator Other External Fixation

    Establishment Types

    Manufacture Medical Device