BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    ACL TightRope Double Bundle

    Reg #: 3019269298 · FEI: 3019269298 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Arthrex Australia Pty Ltd.
    Registration Number
    3019269298
    FEI Number
    3019269298
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite 501, 20 Rodborough Road
    City
    Frenchs Forest New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K101837

    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
    Suture, Nonabsorbable, Silk GAP
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Pin, Fixation, Smooth HTY

    Proprietary Names

    ACL TightRope Double Bundle

    Establishment Types

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