BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Arthrex Korea Ltd.

    Reg #: 3013700547 · FEI: 3013700547 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    71
    Establishment Types
    1
    Classifications
    36

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    Registration Details

    Registration Name
    Arthrex Korea Ltd.
    Registration Number
    3013700547
    FEI Number
    3013700547
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parnas Tower, 20th Floor, 521 Teheran-ro
    City
    Gangnam-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K092381

    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
    Template HWT
    Instrument, Cutting, Orthopedic HTZ
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Screw, Fixation, Bone HWC
    Apparatus, Traction, Non-Powered HST
    Staple, Fixation, Bone JDR
    Arthroscope HRX
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Camera, Surgical And Accessories KQM
    Bit, Drill HTW
    Pin, Fixation, Smooth HTY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Washer, Bolt Nut HTN
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Reamer HTO
    Table And Attachments, Operating-Room BWN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Suture, Nonabsorbable, Silk GAP
    Gauge, Depth HTJ
    Instrument, Manual, Surgical, General Use MDM
    Component, Traction, Non-Invasive KQZ
    Punch, Surgical LRY
    Bur, Surgical, General & Plastic Surgery GFF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Camera, Cine, Endoscopic, Without Audio FWL
    Syringe, Piston FMF
    Orthopedic Manual Surgical Instrument LXH
    Medical Device Data System OUG
    Protector, Skin Pressure FMP
    Operating Room Accessories Table Tray FWZ
    Accessories, Arthroscopic NBH

    Proprietary Names

    iBalance Orthopedic Template orthopedic manual instrument OSTEOTOMY PLATE SHOULDER HOLDER Apparatus, Traction, Non-Powered PUSHLOCK COMPRESSION STAPLE Dual Wave Pump Arthrex Plates, Screws, and Staples Camera Heads drill bit BIO-PIN Arthrex Low Profile Screws FASTAK SUTURE ANCHOR CORKSCREW ANCHORS Arthrex Distal Extremity Plate System SHAVER SYSTEM WASHER Arthrex Tibial GraftBolt TAK FAMILY HUMERAL FRACTURE PLATE Table Attachments, Operating-Room Arthrex PCL TightRope Arthrex Suture OPES ELECTRODES AND ACCESSORIES RF device, blade, hook RETROBUTTON Instrument, manual, surgical, general use ARTHROERESIS IMPLANT Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories BIO-ABSORBABLE CORKSCREW Component, Traction, Non-Invasive VARIOUS BURS smooth or threaded metallic bone fixation fastener Arthroscopes Arthrex Fracture System CONTINUOUS WAVE III BIOCOMPOSITE SUTURE ANCHORS Arthrex Pushlock UNIVERS II BIO-CORKSCREW FT SHAVER BLADES Laproscopes CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT BIO-COMPRESSION SCREW fixation plate LOW PROFILE PLATE AND SCREW SYSTEM TENODESIS FAMILY DOUBLE SYRINGE (ACP) SYSTEM Bio-Composite SutureTak ORTHOPEDIC MANUAL INSTRUMENTS Fracture Plates & Screws Arthrex BioComposite SutureTak BIOCOMPOSITE INTERFERENCE SCREW single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Fracture Plates Arthroscope General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Arthrex Ankle Fusion Plating System VARIOUS IMPLANTS ARTHROSCOPY LEG HOLDER VARIOUS INSTRUMENTS Arthrex Tibial GraftBolt Arthrex SwiveLock Anchors INTERFERENCE SCREWS

    Establishment Types

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