BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Arthrex Mexico, S.A. de C.V.

    Reg #: 3011230048 · FEI: 3011230048 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    75
    Establishment Types
    1
    Classifications
    39

    Registration Details

    Registration Name
    Arthrex Mexico, S.A. de C.V.
    Registration Number
    3011230048
    FEI Number
    3011230048
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Insurgentes Sur No. 859, Oficina 101
    City
    Col. Napoles Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K091844

    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
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Washer, Bolt Nut HTN
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Operating Room Accessories Table Tray FWZ
    System, X-Ray, Angiographic IZI
    Plate, Fixation, Bone HRS
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Protector, Skin Pressure FMP
    Clamp HXD
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Bur, Surgical, General & Plastic Surgery GFF
    Camera, Surgical And Accessories KQM
    Apparatus, Traction, Non-Powered HST
    Pin, Fixation, Smooth HTY
    Bit, Drill HTW
    Suture, Nonabsorbable, Silk GAP
    Instrument, Manual, Surgical, General Use MDM
    Orthopedic Manual Surgical Instrument LXH
    Cerclage, Fixation JDQ
    Table And Attachments, Operating-Room BWN
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Punch, Surgical LRY
    Probe HXB
    Staple Driver HXJ
    Staple, Fixation, Bone JDR
    Syringe, Piston FMF
    Template HWT
    Gauge, Depth HTJ
    Accessories, Arthroscopic NBH
    Reamer HTO
    Medical Device Data System OUG
    Instrument, Cutting, Orthopedic HTZ
    Component, Traction, Non-Invasive KQZ
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Bio-Composite SutureTak ARTHROERESIS IMPLANT Arthroscopes VARIOUS IMPLANTS SHAVER SYSTEM single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes ARTHROSCOPY LEG HOLDER Arthrex Low Profile Screws Arthrex BioComposite SutureTak Arthrex Fracture System fixation plate LOW PROFILE PLATE AND SCREW SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT OPES ELECTRODES AND ACCESSORIES RF device, blade, hook TENODESIS FAMILY Arthrex Tibial GraftBolt BIO-CORKSCREW FT General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Mini TightRope CMC Clamp MENISCAL CINCH Arthrex Tibial GraftBolt Laproscopes Arthrex Fracture Plates VARIOUS BURS Camera Heads SHOULDER HOLDER Apparatus, Traction, Non-Powered BIO-PIN smooth or threaded metallic bone fixation fastener Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories drill bit Arthrex SwiveLock Anchors PUSHLOCK FASTAK SUTURE ANCHOR WASHER RETROBUTTON Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS BIO-ABSORBABLE CORKSCREW BIOCOMPOSITE INTERFERENCE SCREW Fracture Plates & Screws BIOCOMPOSITE SUTURE ANCHORS Dual Wave Pump Table Attachments, Operating-Room FiberTape Fiberstick FiberWire Arthrex Suture SHAVER BLADES HUMERAL FRACTURE PLATE orthopedic manual instrument INTERFERENCE SCREWS DOUBLE SYRINGE (ACP) SYSTEM fixation pin Orthopedic Template Arthrex Plates, Screws, and Staples VARIOUS INSTRUMENTS Arthrex PCL TightRope Arthrex MicroSuture Anchors Arthrex Distal Extremity Plate System TAK FAMILY CONTINUOUS WAVE III OSTEOTOMY PLATE Arthrex Pushlock ACL TightRope Component, Traction, Non-Invasive FiberStitch Implant CORKSCREW ANCHORS Fastener, Fixation, nondegradable, soft tissue

    Establishment Types

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