BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Arthrex Japan G.K. (Shinjuku)

    Reg #: 3012470322 · FEI: 3012470322 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    31

    Registration Details

    Registration Name
    Arthrex Japan G.K. (Shinjuku)
    Registration Number
    3012470322
    FEI Number
    3012470322
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Shinjuku NS BLDG 28F, 2-4-1 Nishi-Shinjuku
    City
    Shinjuku-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K080111

    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
    Staple, Fixation, Bone JDR
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Instrument, Manual, Surgical, General Use MDM
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Guide, Drill, Ligament LXI
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Punch, Surgical LRY
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Biopsy KNW
    Light, Surgical, Fiberoptic FST
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Arthroplasty Implantation System QHE
    System, Image Processing, Radiological LLZ
    Orthopedic Manual Surgical Instrument LXH
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tray, Surgical, Instrument FSM
    Apparatus, Traction, Non-Powered HST
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Syringe, Piston FMF
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Laparoscopic HIF
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Needle, Suturing, Disposable GAB
    Instrument, Special Lens, For Endoscope FEI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Accessories, Arthroscopic NBH

    Proprietary Names

    COMPRESSION STAPLE Instrument, manual, surgical, general use fixation plate LOW PROFILE PLATE AND SCREW SYSTEM orthopedic manual instrument Arthrex Distal Extremity Plate System Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Arthrex Fracture System ORTHOPEDIC MANUAL INSTRUMENTS Laproscopes SHAVER BLADES SHOULDER HOLDER Apparatus, Traction, Non-Powered Syringe, piston Insufflator 50L FM134 single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes PARS Needle Instrument, Special Lens, For Endoscope VARIOUS INSTRUMENTS Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories

    Establishment Types

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