BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    Arthrex New Zealand Limited

    Reg #: 3020704423 · FEI: 3020704423 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    83
    Establishment Types
    1
    Classifications
    45

    Registration Details

    Registration Name
    Arthrex New Zealand Limited
    Registration Number
    3020704423
    FEI Number
    3020704423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Fox Street
    City
    Auckland
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K172612

    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, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Plate, Fixation, Bone HRS
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Cerclage, Fixation JDQ
    Pin, Fixation, Smooth HTY
    Washer, Bolt Nut HTN
    Suture, Nonabsorbable, Silk GAP
    Shoulder Prosthesis, Reverse Configuration PHX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Display, Cathode-Ray Tube, Medical DXJ
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Rod, Fixation, Intramedullary And Accessories HSB
    Camera, Surgical And Accessories KQM
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    System, X-Ray, Angiographic IZI
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Laparoscopic HIF
    Component, Traction, Non-Invasive KQZ
    Staple Driver HXJ
    Staple, Fixation, Bone JDR
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Finger Cot LZB
    Forceps HTD
    Syringe, Piston FMF
    Shoulder Arthroplasty Implantation System QHE
    System, Image Processing, Radiological LLZ
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Bone Wedge PLF
    Tubing, Noninvasive GAZ
    Bur, Surgical, General & Plastic Surgery GFF
    Reamer HTO
    Pliers, Surgical HTC
    Source, Carrier, Fiberoptic Light EQH
    Passer HWQ
    Balance, Analytical JQO
    Protector, Skin Pressure FMP
    Table And Attachments, Operating-Room BWN
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Medical Device Data System OUG

    Proprietary Names

    Arthrex Minimally Invasive Ankle Fusion Plate Arthrex Low Profile Screws RETROBUTTON Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Camera Heads MINI TIGHTROPE BI-CORTICAL BIO-POST AND WASHER Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture Fracture Plates & Screws Arthrex SwiveLock Anchors Arthrex Pushlock Insufflator 50L FM134 Arthrex Distal Extremity Plate System Arthrex PCL TightRope ACL TightRope UNIVERS SHOULDER Component, Traction, Non-Invasive orthopedic manual instrument Fastener, Fixation, nondegradable, soft tissue fixation plate single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Fracture Plates CORKSCREW ANCHORS SHAVER SYSTEM BIO-PIN WASHER FINGERSHIELD UNIVERS II CONTINUOUS WAVE III MENISCAL DART, DARTSTICK, CHONDRAL DART COMPRESSION STAPLE BIO-COMPRESSION SCREW Metallic Bone Fixation Biosync Bone wedge Biosync ARTHROERESIS IMPLANT Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories VARIOUS BURS display, cathode-ray tube, medical Pliers, Surgical Source, Carrier, Fiberoptic Light Arthrex Knotless SutureTak Anchor Graft Delivery Device with Integrated Stylet Dual Wave Pump Orthopedic manual surgical instrument, Passer Balance, Analytical PUSHLOCK Arthrex MicroSuture Anchors DOUBLE SYRINGE (ACP) SYSTEM Arthrex Plates, Screws, and Staples General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure FASTAK SUTURE ANCHOR BIOCOMPOSITE SUTURE ANCHORS Table Attachments, Operating-Room TENODESIS FAMILY Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Arthrex Fracture System INTERFERENCE SCREWS Bio-Composite SutureTak LOW PROFILE PLATE AND SCREW SYSTEM BIOCOMPOSITE INTERFERENCE SCREW OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Arthroscopes Arthrex Univers Apex Arthrex Ankle Fusion Plating System Arthrex BioComposite SutureTak TAK FAMILY Arthrex Suture fixation pin OSTEOTOMY PLATE Mini TightRope CMC smooth or threaded metallic bone fixation fastener

    Establishment Types

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