BEUDAMED
    FDA Registration Active 🇨🇳 China

    Arthrex (Shanghai) Co., Ltd.

    Reg #: 3014262693 · FEI: 3014262693 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    66
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    Arthrex (Shanghai) Co., Ltd.
    Registration Number
    3014262693
    FEI Number
    3014262693
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2205-2208 Garden Square, 968 Beijing West Road
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K103705

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Punch, Surgical LRY
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Washer, Bolt Nut HTN
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Apparatus, Traction, Non-Powered HST
    Arthroscope HRX
    Camera, Television, Surgical, Without Audio FWB
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Orthopedic Manual Surgical Instrument LXH
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    System, Image Processing, Radiological LLZ
    Staple, Fixation, Bone JDR
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Pin, Fixation, Smooth HTY
    Cerclage, Fixation JDQ
    Instrument, Special Lens, For Endoscope FEI
    Guide, Drill, Ligament LXI
    Syringe, Piston FMF
    Template HWT
    Gauge, Depth HTJ
    Accessories, Arthroscopic NBH
    Bit, Drill HTW
    Suture, Nonabsorbable, Silk GAP
    Reamer HTO
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Shoulder Arthroplasty Implantation System QHE
    Instrument, Manual, Surgical, General Use MDM
    Staple Driver HXJ

    Proprietary Names

    Arthrex Low Profile Screws FiberTape Fiberstick FiberWire orthopedic manual instrument Bio-Composite SutureTak INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT SHOULDER HOLDER Apparatus, Traction, Non-Powered smooth or threaded metallic bone fixation fastener CONTINUOUS WAVE III Dual Wave Pump TENODESIS FAMILY TAK FAMILY Camera, Television, Surgical, Without Audio Arthroscopes ORTHOPEDIC MANUAL INSTRUMENTS Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi COMPRESSION STAPLE single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex PCL TightRope Mini TightRope CMC fixation pin Arthrex Tibial GraftBolt PUSHLOCK CORKSCREW ANCHORS Instrument, Special Lens, For Endoscope Arthrex MicroSuture Anchors DOUBLE SYRINGE (ACP) SYSTEM fixation plate LOW PROFILE PLATE AND SCREW SYSTEM OSTEOTOMY PLATE Arthrex Biocomposite Transfix Orthopedic Template Arthrex Plates, Screws, and Staples Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories INTERFERENCE SCREWS ACL TightRope BIOCOMPOSITE SUTURE ANCHORS Arthrex BioComposite SutureTak Arthrex Pushlock MENISCAL CINCH Arthrex Ankle Fusion Plating System VARIOUS INSTRUMENTS drill bit Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Fracture Plates & Screws VARIOUS IMPLANTS ACL TightRope Double Bundle Fastener, Fixation, nondegradable, soft tissue Laproscopes UNIVERS II Arthrex Fracture Plates WASHER RETROBUTTON BIOCOMPOSITE INTERFERENCE SCREW SHAVER BLADES SHAVER SYSTEM Instrument, manual, surgical, general use Arthrex Suture Arthrex Distal Extremity Plate System Arthrex Tibial GraftBolt Arthrex SwiveLock Anchors

    Establishment Types

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