BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Arthrex Japan G.K. (Shinjuku)

    Reg #: 3012470322 · FEI: 3012470322 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Arthrex Japan G.K. (Shinjuku)
    Registration Number
    3012470322
    FEI Number
    3012470322
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Shinjuku NS BLDG 28F, 2-4-1 Nishi-Shinjuku
    City
    Shinjuku-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K222161

    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 ext. 76939

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Establishment Types

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