BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Single/multiple component metallic bone fixation appliances and accessories

    Reg #: 3013700547 · FEI: 3013700547 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Arthrex Korea Ltd.
    Registration Number
    3013700547
    FEI Number
    3013700547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parnas Tower, 20th Floor, 521 Teheran-ro
    City
    Gangnam-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K141478

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    Single/multiple component metallic bone fixation appliances and accessories Arthrex Fracture Plates and Screws

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device