BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Arthrex Logistic Center Canada

    Reg #: 3030926959 · FEI: 3030926959 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    29

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    Registration Details

    Registration Name
    Arthrex Logistic Center Canada
    Registration Number
    3030926959
    FEI Number
    3030926959
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    580 Sovereign Road
    City
    London Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K080560

    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
    Arthroscope HRX
    Rod, Fixation, Intramedullary And Accessories HSB
    Apparatus, Traction, Non-Powered HST
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Gauge, Depth HTJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Insufflator, Laparoscopic HIF
    Laparoscope, General & Plastic Surgery GCJ
    Operating Room Accessories Table Tray FWZ
    Instrument, Special Lens, For Endoscope FEI
    Instrument, Manual, Surgical, General Use MDM
    System, X-Ray, Angiographic IZI
    Controller, Foot, Handpiece And Cord EBW
    Orthopedic Manual Surgical Instrument LXH
    Medical Device Data System OUG
    Template HWT
    Table And Attachments, Operating-Room BWN
    Bit, Drill HTW
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Tray, Surgical, Instrument FSM
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Camera, Surgical And Accessories KQM
    Light, Surgical, Fiberoptic FST
    Dressing, Wound, Drug FRO
    Protector, Skin Pressure FMP
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Component, Traction, Non-Invasive KQZ

    Proprietary Names

    Arthroscopes SHOULDER HOLDER Apparatus, Traction, Non-Powered Accessories, Photographic, For Endoscope (Exclude Light Sources) orthopedic manual instrument SHAVER SYSTEM 40 L HIGH FLOW INSUFFLATOR F108 ARTHROSCOPY LEG HOLDER Instrument, Special Lens, For Endoscope Instrument, manual, surgical, general use AR-200 - Clips CONTINUOUS WAVE III ORTHOPEDIC MANUAL INSTRUMENTS Orthopedic Template Table Attachments, Operating-Room drill bit Laproscopes Camera Heads Procellera Composite Antibacterial Wound Dressing General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Component, Traction, Non-Invasive

    Establishment Types

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