BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Arthrex Australia Pty Ltd.

    Reg #: 3019269298 · FEI: 3019269298 · Expires 2026
    View on FDA
    Products
    63
    Proprietary Names
    114
    Establishment Types
    1
    Classifications
    63

    Registration Details

    Registration Name
    Arthrex Australia Pty Ltd.
    Registration Number
    3019269298
    FEI Number
    3019269298
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 501, 20 Rodborough Road
    City
    Frenchs Forest New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K203495

    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
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Cerclage, Fixation JDQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Arthroscope HRX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Pin, Fixation, Smooth HTY
    Syringe, Piston FMF
    Laparoscope, General & Plastic Surgery GCJ
    Washer, Bolt Nut HTN
    Suture, Nonabsorbable, Silk GAP
    Protector, Skin Pressure FMP
    Staple, Fixation, Bone JDR
    Probe HXB
    Bur, Surgical, General & Plastic Surgery GFF
    Tubing, Noninvasive GAZ
    Balance, Analytical JQO
    Shoulder Prosthesis, Reverse Configuration PHX
    Display, Cathode-Ray Tube, Medical DXJ
    Source, Carrier, Fiberoptic Light EQH
    Forceps HTD
    Staple Driver HXJ
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Laparoscopic HIF
    Expander, Surgical, Skin Graft FZW
    Passer HWQ
    Orthopedic Manual Surgical Instrument LXH
    Reamer HTO
    Table And Attachments, Operating-Room BWN
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Controller, Foot, Handpiece And Cord EBW
    Bit, Drill HTW
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Camera, Surgical And Accessories KQM
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Instrument, Manual, Surgical, General Use MDM
    Template HWT
    Accessories, Arthroscopic NBH
    Needle, Suturing, Disposable GAB
    Rod, Fixation, Intramedullary And Accessories HSB
    Apparatus, Traction, Non-Powered HST
    Component, Traction, Non-Invasive KQZ
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Camera, Television, Surgical, Without Audio FWB
    Gauge, Depth HTJ
    Tray, Surgical, Instrument FSM
    System, X-Ray, Angiographic IZI
    Medical Device Data System OUG
    Pliers, Surgical HTC
    Punch, Surgical LRY
    System, Digital Image Communications, Radiological LMD
    System, Image Processing, Radiological LLZ
    Bone Wedge PLF
    Staple, Absorbable MNU
    Instrument, Cutting, Orthopedic HTZ
    Operating Room Accessories Table Tray FWZ

    Proprietary Names

    Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Arthrex Distal Extremity Plate System Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Arthrex Suture Dual Wave Pump Arthrex Minimally Invasive Ankle Fusion Plate BIO-CORKSCREW FT UNIVERS II fixation plate Arthroscope Arthrex Fracture System UNIVERS SHOULDER Arthroscopes BIO-ABSORBABLE CORKSCREW General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure BI-CORTICAL BIO-POST AND WASHER BIO-FASTAK SUTURE ANCHOR CORKSCREW ANCHORS Arthrex PushLock Tenodesis Anchor orthopedic manual instrument VARIOUS BURS Mini TightRope CMC Laproscopes TAK FAMILY ACL TightRope Balance, Analytical Arthrex Tibial GraftBolt display, cathode-ray tube, medical BIO-PIN Arthrex Fracture Plates Source, Carrier, Fiberoptic Light UNIVERS FRACTURE Bio-Composite SutureTak BIO-COMPRESSION SCREW BIOCOMPOSITE INTERFERENCE SCREW SHAVER BLADES Insufflator 50L FM134 fixation pin Orthopedic manual surgical instrument, Passer Arthrex BioComposite SutureTak Arthrex Tibial GraftBolt DOUBLE SYRINGE (ACP) SYSTEM Arthrex Plates, Screws, and Staples LOW PROFILE PLATE AND SCREW SYSTEM Arthrex MicroSuture Anchors ORTHOPEDIC MANUAL INSTRUMENTS FiberTape Fiberstick FiberWire Table Attachments, Operating-Room Arthrex SwiveLock Anchors SHAVER SYSTEM Arthrex Graft-Anchor drill bit ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P MENISCAL CINCH Arthrex Ankle Fusion Plating System VARIOUS IMPLANTS BIOCOMPOSITE SUTURE ANCHORS Camera Heads MENISCAL DART, DARTSTICK, CHONDRAL DART Instrument, manual, surgical, general use Orthopedic Template ACL TightRope Double Bundle INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT VARIOUS INSTRUMENTS ARTHROERESIS IMPLANT COMPRESSION STAPLE PARS Needle iBalance DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER HUMERAL FRACTURE PLATE Fracture Plates & Screws Arthrex Univers II Glenoid Components TENODESIS FAMILY Univers II SHOULDER HOLDER Apparatus, Traction, Non-Powered Graft Delivery Device with Integrated Stylet Component, Traction, Non-Invasive Camera, Television, Surgical, Without Audio smooth or threaded metallic bone fixation fastener OSTEOTOMY SYSTEM INTERFERENCE SCREWS PUSHLOCK RETROBUTTON Arthrex PCL TightRope OSTEOTOMY PLATE Arthrex Low Profile Screws Arthrex Knotless SutureTak Anchor single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes FASTAK SUTURE ANCHOR Pliers, Surgical Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System System, Digital Image Communications, Radiological Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Metallic Bone Fixation Biosync Bone wedge Biosync BIO-POST AND WASHER FIBERWIRE BUTTON REPAIR KIT WASHER Fastener, Fixation, nondegradable, soft tissue ARTHROSCOPY LEG HOLDER Arthrex Pushlock OPES ELECTRODES AND ACCESSORIES RF device, blade, hook

    Establishment Types

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