BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arthrex, Inc.

    Reg #: 3010331645 · FEI: 3010331645 · Expires 2026
    View on FDA
    Products
    103
    Proprietary Names
    163
    Establishment Types
    2
    Classifications
    103

    Registration Details

    Registration Name
    Arthrex, Inc.
    Registration Number
    3010331645
    FEI Number
    3010331645
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6875 Arthrex Commerce Drive
    City
    Ave Maria
    State
    FL
    ZIP
    34142
    Country
    US

    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

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Rod, Fixation, Intramedullary And Accessories HSB
    Needle, Suturing, Disposable GAB
    Screw, Fixation, Bone HWC
    Tray, Surgical, Instrument FSM
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Operating Room Accessories Table Tray FWZ
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Arthroplasty Implantation System QHE
    System, Image Processing, Radiological LLZ
    Wrench HXC
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Pin, Fixation, Smooth HTY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Cerclage, Fixation JDQ
    Punch, Surgical LRY
    Passer HWQ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Source, Carrier, Fiberoptic Light EQH
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Forceps, General & Plastic Surgery GEN
    Reamer HTO
    Syringe, Piston FMF
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Retention Device, Suture KGS
    Pliers, Surgical HTC
    Twister, Wire HXS
    Clamp HXD
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Biopsy KNW
    Mallet HXL
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Instrument, Special Lens, For Endoscope FEI
    Staple, Fixation, Bone JDR
    Arthroscope HRX
    Suture, Nonabsorbable, Silk GAP
    Guide, Drill, Ligament LXI
    Pin, Fixation, Threaded JDW
    Probe HXB
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Sterilizer, Steam FLE
    Bender HXW
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Instrument, Manual, Surgical, General Use MDM
    Camera, Surgical And Accessories KQM
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Forceps HTD
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Support, Patient Position CCX
    Component, Traction, Non-Invasive KQZ
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Table And Attachments, Operating-Room BWN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Template HWT
    Medical Device Data System OUG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Insufflator, Laparoscopic HIF
    Bone Wedge PLF
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Staple, Absorbable MNU
    Catheter, Irrigation GBX
    Display, Cathode-Ray Tube, Medical DXJ
    Dressing, Compression MHW
    Instrument, Cutting, Orthopedic HTZ
    Holder, Camera, Surgical FXR
    System, Facet Screw Spinal Device MRW
    Finger Cot LZB
    Light, Surgical, Fiberoptic FST
    Camera, Television, Surgical, Without Audio FWB
    Driver, Prosthesis HWR
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Confocal Optical Imaging OWN
    Mesh, Surgical, Polymeric FTL
    Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon OWX
    Bur, Surgical, General & Plastic Surgery GFF
    Staple Driver HXJ
    Protector, Skin Pressure FMP
    Bit, Drill HTW
    Controller, Foot, Handpiece And Cord EBW
    Gauge, Depth HTJ
    Expander, Surgical, Skin Graft FZW
    Tubing, Noninvasive GAZ
    System, Digital Image Communications, Radiological LMD
    Saw, Powered, And Accessories HAB
    Drape, Surgical, Exempt PUI
    Insufflator, Endoscopic Vessel Harvesting OSV
    Apparatus, Traction, Non-Powered HST
    Hook, Bone KIK
    Handle, Scalpel GDZ
    Wrap, Sterilization FRG
    Accessories, Arthroscopic NBH

    Proprietary Names

    PARS Needle PUSHLOCK orthopedic manual instrument WASHER Arthrex Biocomposite Transfix SHAVER BLADES ARTHROSCOPY LEG HOLDER Wrench Arthrex Low Profile Screws Orthopedic manual surgical instrument, Passer Source, Carrier, Fiberoptic Light ORTHOPEDIC MANUAL INSTRUMENTS UNIVERS SHOULDER Forceps, General & Plastic Surgery Arthrex Fracture System Arthrex MicroSuture Anchors BIO-BUTTON Pliers, Surgical TWISTER, WIRE Clamp SHAVER SYSTEM Fracture Plates & Screws Arthrex Tibial GraftBolt Mallet ACL TightRope Mini TightRope CMC ACCIN Patellofemoral System Instrument, Special Lens, For Endoscope Arthrex Plates, Screws, and Staples Arthrex SwiveLock Anchors Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi Arthrex Fracture Plates CONTINUOUS WAVE III FiberTak DR Arthrex BioComposite SutureTak Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System AOS HUMERAL NAI single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes ACL TightRope Double Bundle BIOCOMPOSITE INTERFERENCE SCREW CONTAINER SYSTEM BENDER bone void filler Stimublast BIO-COMPRESSION SCREW FIBERTAPE Instrument, manual, surgical, general use BIO-ABSORBABLE CORKSCREW Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener DOUBLE SYRINGE (ACP) SYSTEM Arthrex BioSuture Nonabsorbable poly(ethylene terephthalate) Surgical Suture UNIVERS II Single/multiple component metallic bone fixation appliances and accessories Arthrex Compression Plates OSTEOTOMY SYSTEM Camera Heads BIO-FASTAK SUTURE ANCHOR Arthrex Suture smooth or threaded metallic bone fixation fastener BIO-CORKSCREW FT Dual Wave Pump Arthrex Tibial GraftBolt CORKSCREW ANCHORS Arthrex Graft-Anchor SUPPORT, PATIENT POSITION ARTHROSCOPY PUMP Component, Traction, Non-Invasive Syringe, piston RETROBUTTON BIOCOMPOSITE Arthrex Small External Fixation System ARTHROERESIS IMPLANT Table Attachments, Operating-Room ACCIN Uni-Knee System Orthopedic Template Univers II BIO-PIN fixation pin INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Arthroscopes 40 L HIGH FLOW INSUFFLATOR F108 FIBERWIRE BUTTON REPAIR KIT PROSTOP PLUS MENISCAL CINCH Metallic Bone Fixation Biosync Bone wedge Biosync iBalance Arthrex PCL TightRope Accessories, Photographic, For Endoscope (Exclude Light Sources) MENISCAL DART, DARTSTICK, CHONDRAL DART MINI TIGHTROPE BIO-POST AND WASHER BIOCOMPOSITE SUTURE ANCHORS Laproscopes Catheter, Irrigation Dressing, Compression Elastic bandage Holder, Camera, Surgical Arthrex PushLock Tenodesis Anchor Arthrex Knotless SutureTak Anchor DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER FINGERSHIELD Arthroscope Arthrex Pushlock FASTAK SUTURE ANCHOR HUMERAL FRACTURE PLATE OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Camera, Television, Surgical, Without Audio TENODESIS FAMILY Driver, Prosthesis cart, emergency, cardiopulmonary INTERFERENCE SCREWS ACCIN Total Knee System knee joint patellofemorotibial polymer/metal/polymer semi-constrained Arthrex iBalance Patella Implant, Dome Fastener, Fixation, nondegradable, soft tissue Arthrex Minimally Invasive Ankle Fusion Plate Arthrex PushLock VARIOUS BURS TAK FAMILY Arthrex Fracture Plates and Screws Arthrex Univers Apex General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure OSTEOTOMY PLATE drill bit FiberTape Fiberstick FiberWire Arthrex iBalance TKA System Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis BI-CORTICAL BIO-POST AND WASHER TRIM-IT FAMILY Arthrex Distal Extremity Plate System Arthrex FiberTak Suture Anchors COMPRESSION STAPLE System, Digital Image Communications, Radiological VARIOUS IMPLANTS saw blade fixation plate Drape, Surgical, Exempt Insufflator 50L FM134 LOW PROFILE PLATE AND SCREW SYSTEM SHOULDER HOLDER Apparatus, Traction, Non-Powered hook, bone MINI BIO-ANCHOR handle, scalpel AESCULAP STERILCONTAINER SYSTEM Bio-Composite SutureTak VARIOUS INSTRUMENTS Arthrex Univers CA Heads Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Arthrex iBalance BiCompartmental Arthroplasty System Arthrex Ankle Fusion Plating System INTERFERENCE SCREW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)