BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Arthrex GmbH

    Reg #: 3002579136 · FEI: 3002579136 · Expires 2026
    View on FDA
    Products
    65
    Proprietary Names
    96
    Establishment Types
    2
    Classifications
    65

    Registration Details

    Registration Name
    Arthrex GmbH
    Registration Number
    3002579136
    FEI Number
    3002579136
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Erwin-Hielscher-Strasse 9
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232973

    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
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Arthroscope HRX
    Accessories, Arthroscopic NBH
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Camera, Surgical And Accessories KQM
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Template HWT
    Plate, Fixation, Bone HRS
    Forceps HTD
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Pin, Fixation, Smooth HTY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Shoulder Prosthesis, Reverse Configuration PHX
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Washer, Bolt Nut HTN
    Clamp HXD
    Syringe, Piston FMF
    Instrument, Special Lens, For Endoscope FEI
    Balance, Analytical JQO
    Staple, Fixation, Bone JDR
    Camera, Cine, Endoscopic, Without Audio FWL
    Cerclage, Fixation JDQ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Apparatus, Traction, Non-Powered HST
    System, Image Processing, Radiological LLZ
    Guide, Drill, Ligament LXI
    Suture, Nonabsorbable, Silk GAP
    Orthopedic Manual Surgical Instrument LXH
    Camera, Television, Surgical, Without Audio FWB
    Tubing, Noninvasive GAZ
    Saw, Powered, And Accessories HAB
    Bit, Drill HTW
    Display, Cathode-Ray Tube, Medical DXJ
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Passer HWQ
    Component, Traction, Non-Invasive KQZ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Expander, Surgical, Skin Graft FZW
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Medical Device Data System OUG
    Sterilizer, Steam FLE
    Shoulder Arthroplasty Implantation System QHE
    Table And Attachments, Operating-Room BWN
    Tray, Surgical, Instrument FSM
    Operating Room Accessories Table Tray FWZ
    Staple Driver HXJ
    Gauge, Depth HTJ
    Bur, Surgical, General & Plastic Surgery GFF
    Instrument, Manual, Surgical, General Use MDM
    Syringe, Irrigating (Non Dental) KYZ
    Probe HXB
    Wrap, Sterilization FRG
    Reamer HTO
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Instrument, Cutting, Orthopedic HTZ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    MENISCAL CINCH VARIOUS INSTRUMENTS TENODESIS FAMILY Camera Heads ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P Laproscopes Arthroscopes Orthopedic Template Dual Wave Pump orthopedic manual instrument SHAVER BLADES UNIVERS FRACTURE Fastener, Fixation, nondegradable, soft tissue BIO-COMPRESSION SCREW Arthrex Low Profile Screws Univers II Arthrex BioComposite SutureTak FiberStitch Implant SHAVER SYSTEM Arthrex Fracture Plates Mini TightRope CMC Clamp DOUBLE SYRINGE (ACP) SYSTEM Arthrex Univers Apex Shoulder joint metal/ polymer semi-constrained cemented prosthesis INTERFERENCE SCREWS Instrument, Special Lens, For Endoscope INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT BIOCOMPOSITE SUTURE ANCHORS Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Univers Revers Shoulder Prosthesis System Balance, Analytical Arthrex Plates, Screws, and Staples Arthrex Ankle Fusion Plating System Bio-Composite SutureTak CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO Arthroscope Arthrex SwiveLock Anchors Fracture Plates & Screws SHOULDER HOLDER Apparatus, Traction, Non-Powered Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi ARTHROSCOPY PUMP TAK FAMILY UNIVERS SHOULDER Syringe, piston BIO-ABSORBABLE CORKSCREW HUMERAL FRACTURE PLATE fixation pin ORTHOPEDIC MANUAL INSTRUMENTS BIO-CORKSCREW FT Camera, Television, Surgical, Without Audio PUSHLOCK saw blade FiberTape Fiberstick FiberWire fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Arthrex PushLock BI-CORTICAL BIO-POST AND WASHER drill bit display, cathode-ray tube, medical Orthopedic manual surgical instrument, Passer BIO-PIN Component, Traction, Non-Invasive CORKSCREW ANCHORS Arthrex iBalance BiCompartmental Arthroplasty System Arthrex MicroSuture Anchors CONTAINER SYSTEM Arthrex Biocomposite Transfix BIOCOMPOSITE INTERFERENCE SCREW MINI BIO-ANCHOR single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes RETROBUTTON Arthrex Pushlock Table Attachments, Operating-Room CONTINUOUS WAVE III UNIVERS II ARTHROSCOPY LEG HOLDER VARIOUS BURS Viscogel/Viscospray Instrument, manual, surgical, general use Syringe, Irrigating (Non Dental) AESCULAP STERILCONTAINER SYSTEM Arthrex Suture MENISCAL DART, DARTSTICK, CHONDRAL DART Arthrex Univers II Glenoid Components WASHER Sutter CURIS RF Generator Arthroscope Sheath cart, emergency, cardiopulmonary

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility