BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Arthrex Distribution Hub EMEA B.V.

    Reg #: 3016851379 · FEI: 3016851379 · Expires 2026
    View on FDA
    Products
    83
    Proprietary Names
    158
    Establishment Types
    1
    Classifications
    83

    Registration Details

    Registration Name
    Arthrex Distribution Hub EMEA B.V.
    Registration Number
    3016851379
    FEI Number
    3016851379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Amperestraat 9
    City
    Venlo Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K123341

    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
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Shoulder Prosthesis, Reverse Configuration PHX
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Suture, Nonabsorbable, Silk GAP
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Sterilizer, Steam FLE
    Pin, Fixation, Smooth HTY
    Staple, Fixation, Bone JDR
    Instrument, Cutting, Orthopedic HTZ
    Plate, Fixation, Bone HRS
    Rod, Fixation, Intramedullary And Accessories HSB
    Finger Cot LZB
    System, Image Processing, Radiological LLZ
    Instrument, Special Lens, For Endoscope FEI
    Probe HXB
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Filler, Bone Void, Calcium Compound MQV
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Guide, Drill, Ligament LXI
    Reamer HTO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Wrap, Sterilization FRG
    Medical Device Data System OUG
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Cerclage, Fixation JDQ
    Syringe, Piston FMF
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Shoulder Arthroplasty Implantation System QHE
    Dressing, Wound, Drug FRO
    Display, Cathode-Ray Tube, Medical DXJ
    Forceps HTD
    Instrument, Manual, Surgical, General Use MDM
    Orthopedic Manual Surgical Instrument LXH
    Bone Wedge PLF
    Clamp HXD
    System, X-Ray, Angiographic IZI
    Tray, Surgical, Instrument FSM
    Punch, Surgical LRY
    Component, Traction, Non-Invasive KQZ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Template HWT
    Dressing, Compression MHW
    Saw, Powered, And Accessories HAB
    Operating Room Accessories Table Tray FWZ
    Goniometer, Ac-Powered KQX
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Table And Attachments, Operating-Room BWN
    Staple Driver HXJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Tubing, Noninvasive GAZ
    Dressing, Wound, Hydrophilic NAC
    Adaptor, Holder, Syringe IQG
    Camera, Surgical And Accessories KQM
    Accessories, Arthroscopic NBH
    Syringe, Irrigating (Non Dental) KYZ
    Balance, Analytical JQO
    Camera, Television, Surgical, Without Audio FWB
    Needle, Suturing, Disposable GAB
    Gauge, Depth HTJ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Retention Device, Suture KGS
    Expander, Surgical, Skin Graft FZW
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Apparatus, Traction, Non-Powered HST
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Bur, Surgical, General & Plastic Surgery GFF
    Staple, Absorbable MNU
    Camera, Cine, Endoscopic, Without Audio FWL
    Bit, Drill HTW

    Proprietary Names

    Arthrex Univers II Glenoid Components FIBERTAPE Fracture Plates & Screws knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome BI-CORTICAL BIO-POST AND WASHER BIO-ABSORBABLE CORKSCREW Arthrex iBalance BiCompartmental Arthroplasty System CONTAINER SYSTEM BIO-PIN COMPRESSION STAPLE orthopedic manual instrument Arthroscopes BIOCOMPOSITE INTERFERENCE SCREW Arthrex Knotless SutureTak Anchor OSTEOTOMY PLATE ACL TightRope FINGERSHIELD FiberTape Fiberstick FiberWire Arthrex Tibial GraftBolt CORKSCREW ANCHORS BIO-FASTAK SUTURE ANCHOR MENISCAL CINCH Arthrex Minimally Invasive Ankle Fusion Plate PROSTOP PLUS BIO-COMPRESSION SCREW Instrument, Special Lens, For Endoscope smooth or threaded metallic bone fixation fastener Arthrex FiberTak Suture Anchors Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories bone void filler Sutter CURIS RF Generator Laproscopes OSTEOTOMY SYSTEM Arthrex MicroSuture Anchors Arthrex PushLock Tenodesis Anchor Arthrex SwiveLock Anchors AESCULAP STERILCONTAINER SYSTEM Arthrex BioComposite SutureTak WASHER Arthrex Compression Plates FIBERWIRE BUTTON REPAIR KIT SHAVER BLADES Arthrex Low Profile Screws Stimublast COBE Angel Whole Blood Separation System ARTHROSCOPY PUMP Arthrex Fracture Plates UNIVERS SHOULDER PROWICK BIO-CORKSCREW FT HATRIC CONTINUOUS WAVE III DOUBLE SYRINGE (ACP) SYSTEM display, cathode-ray tube, medical Viscogel/Viscospray Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS TRIM-IT FAMILY Arthrex Distal Extremity Plate System Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Metallic Bone Fixation Biosync Bone wedge Biosync Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi UNIVERS FRACTURE Arthrex Pushlock Arthrex Univers II Shoulder Prosthesis ACCIN Uni-Knee System Clamp HUMERAL FRACTURE PLATE Component, Traction, Non-Invasive Orthopedic Template Fastener, Fixation, nondegradable, soft tissue Dressing, Compression Elastic bandage VARIOUS IMPLANTS saw blade ARTHROSCOPY LEG HOLDER Arthrex Fracture System INTERFERENCE SCREWS Table Attachments, Operating-Room PUSHLOCK Arthrex PCL TightRope iBalance BIOCOMPOSITE SHAVER SYSTEM Syringe, piston Arthrex Biocomposite Transfix FiberTak DR DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER Adaptor, Holder, Syringe Arthrex PushLock Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Camera Heads VARIOUS INSTRUMENTS fixation pin Arthroscope Arthrex Graft-Anchor Dual Wave Pump Syringe, Irrigating (Non Dental) RETROBUTTON INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT MINI BIO-ANCHOR Balance, Analytical Arthrex Plates, Screws, and Staples Arthrex Tibial GraftBolt ACL TightRope Double Bundle Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Arthrex Suture FASTAK SUTURE ANCHOR ARTHROERESIS IMPLANT Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System Mini TightRope CMC Arthrex Ankle Fusion Plating System Camera, Television, Surgical, Without Audio PARS Needle cart, emergency, cardiopulmonary Arthrex Univers Apex BIO-BUTTON ACCIN Total Knee System TENODESIS FAMILY INTERFERENCE SCREW MINI TIGHTROPE ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P SHOULDER HOLDER Apparatus, Traction, Non-Powered fixation plate MENISCAL DART, DARTSTICK, CHONDRAL DART BIOCOMPOSITE SUTURE ANCHORS ACCIN Bipolar Head System ACCIN Patellofemoral System Arthroscope Sheath Arthrex iBalance TKA System Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis UNIVERS II FiberStitch Implant OPES ELECTRODES AND ACCESSORIES RF device, blade, hook VARIOUS BURS BIO-POST AND WASHER LOW PROFILE PLATE AND SCREW SYSTEM CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO drill bit single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Bio-Composite SutureTak TAK FAMILY Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture Univers II

    Establishment Types

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