BEUDAMED
    FDA Registration Active 🇨🇴 Colombia

    Arthrex Colombia SAS

    Reg #: 3021226419 · FEI: 3021226419 · Expires 2026
    View on FDA
    Products
    48
    Proprietary Names
    59
    Establishment Types
    1
    Classifications
    48

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    Registration Details

    Registration Name
    Arthrex Colombia SAS
    Registration Number
    3021226419
    FEI Number
    3021226419
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Carrera 11 No. 79-35 Piso 9
    City
    Bogota Cundinamarca
    Country
    CO

    Regulatory Submissions

    510(k) Number
    K021434

    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
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Pin, Fixation, Smooth HTY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Light, Surgical, Fiberoptic FST
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Arthroscope HRX
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, X-Ray, Angiographic IZI
    Laparoscope, General & Plastic Surgery GCJ
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Operating Room Accessories Table Tray FWZ
    System, External Fixator (With Metallic Invasive Components) NDK
    Forceps HTD
    Orthopedic Manual Surgical Instrument LXH
    Reamer HTO
    Camera, Television, Surgical, Without Audio FWB
    Medical Device Data System OUG
    Component, Traction, Non-Invasive KQZ
    Protector, Skin Pressure FMP
    Cerclage, Fixation JDQ
    Suture, Nonabsorbable, Silk GAP
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Gauge, Depth HTJ
    Syringe, Piston FMF
    Insufflator, Laparoscopic HIF
    Bur, Surgical, General & Plastic Surgery GFF
    Apparatus, Traction, Non-Powered HST
    Instrument, Manual, Surgical, General Use MDM
    Insufflator, Endoscopic Vessel Harvesting OSV
    Template HWT
    Punch, Surgical LRY
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Bit, Drill HTW
    Balance, Analytical JQO
    Instrument, Cutting, Orthopedic HTZ
    Filler, Bone Void, Calcium Compound MQV
    Table And Attachments, Operating-Room BWN
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Camera, Surgical And Accessories KQM
    Accessories, Arthroscopic NBH
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    FiberTape Fiberstick FiberWire CONTINUOUS WAVE III single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Low Profile Screws SHAVER BLADES Laproscopes Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories MINI BIO-ANCHOR ACL TightRope ARTHROSCOPY LEG HOLDER Arthroscopes Dual Wave Pump WASHER EXTERNAL FIXATOR SYSTEM orthopedic manual instrument ORTHOPEDIC MANUAL INSTRUMENTS Camera, Television, Surgical, Without Audio ARTHROERESIS IMPLANT Component, Traction, Non-Invasive General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure RETROBUTTON OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Syringe, piston 40 L HIGH FLOW INSUFFLATOR F108 VARIOUS BURS ARTHROSCOPY PUMP SHOULDER HOLDER Apparatus, Traction, Non-Powered MENISCAL CINCH Arthrex Pushlock INTERFERENCE SCREWS Instrument, manual, surgical, general use Insufflator 50L FM134 PROSTOP PLUS FIBERWIRE BUTTON REPAIR KIT smooth or threaded metallic bone fixation fastener Fastener, Fixation, nondegradable, soft tissue Orthopedic Template INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT drill bit Balance, Analytical Mini TightRope CMC TENODESIS FAMILY Arthrex Tibial GraftBolt Table Attachments, Operating-Room Accessories, Photographic, For Endoscope (Exclude Light Sources) Camera Heads VARIOUS INSTRUMENTS Arthrex Fracture System Arthrex PushLock Arthrex Tibial GraftBolt Graft Delivery Device with Integrated Stylet

    Establishment Types

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