BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arthrex Manufacturing Inc.

    Reg #: 3015231789 · FEI: 3015231789 · Expires 2026
    View on FDA
    Products
    84
    Proprietary Names
    136
    Establishment Types
    3
    Classifications
    84

    Registration Details

    Registration Name
    Arthrex Manufacturing Inc.
    Registration Number
    3015231789
    FEI Number
    3015231789
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    130 Arthrex Drive
    City
    Pendleton
    State
    SC
    ZIP
    29670
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130458

    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, Nondegradable, Soft Tissue MBI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Pin, Fixation, Smooth HTY
    Driver, Prosthesis HWR
    Screw, Fixation, Bone HWC
    Laparoscope, General & Plastic Surgery GCJ
    System, X-Ray, Angiographic IZI
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Apparatus, Traction, Non-Powered HST
    Shoulder Prosthesis, Reverse Configuration PHX
    Rod, Fixation, Intramedullary And Accessories HSB
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    System, Image Processing, Radiological LLZ
    Orthopedic Manual Surgical Instrument LXH
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Cerclage, Fixation JDQ
    Bit, Drill HTW
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Washer, Bolt Nut HTN
    Syringe, Piston FMF
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Protector, Skin Pressure FMP
    Source, Carrier, Fiberoptic Light EQH
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Tray, Surgical, Instrument FSM
    Staple Driver HXJ
    Staple, Fixation, Bone JDR
    Suture, Nonabsorbable, Silk GAP
    Guide, Drill, Ligament LXI
    Accessories, Arthroscopic NBH
    Arthroscope HRX
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Instrument, Biopsy KNW
    Catheter, Irrigation GBX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Pliers, Surgical HTC
    Sterilizer, Steam FLE
    Instrument, Manual, Surgical, General Use MDM
    Staple, Absorbable MNU
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Filler, Bone Void, Calcium Compound MQV
    Mesh, Surgical, Polymeric FTL
    Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon OWX
    Shoulder Arthroplasty Implantation System QHE
    Bur, Surgical, General & Plastic Surgery GFF
    Drape, Surgical, Exempt PUI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Wrap, Sterilization FRG
    Template HWT
    Holder, Camera, Surgical FXR
    Forceps HTD
    Mallet HXL
    Balance, Analytical JQO
    System, Facet Screw Spinal Device MRW
    Gauge, Depth HTJ
    Punch, Surgical LRY
    Reamer HTO
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Retention Device, Suture KGS
    Light, Surgical, Fiberoptic FST
    Saw, Powered, And Accessories HAB
    Table And Attachments, Operating-Room BWN
    Instrument, Special Lens, For Endoscope FEI
    Support, Patient Position CCX
    Pin, Fixation, Threaded JDW
    Bone Wedge PLF
    Probe HXB
    Dressing, Compression MHW
    Confocal Optical Imaging OWN
    Needle, Suturing, Disposable GAB
    Wrench HXC
    Controller, Foot, Handpiece And Cord EBW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Instrument, Cutting, Orthopedic HTZ
    Twister, Wire HXS

    Proprietary Names

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

    Establishment Types

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