BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    Arthrex Chile SPA

    Reg #: 3027339877 · FEI: 3027339877 · Expires 2026
    View on FDA
    Products
    42
    Proprietary Names
    68
    Establishment Types
    1
    Classifications
    42

    Registration Details

    Registration Name
    Arthrex Chile SPA
    Registration Number
    3027339877
    FEI Number
    3027339877
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Camino a Noviciado, number: 3707, modulo 13-14
    City
    Pudahuel Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K221354

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US

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

    Proprietary Names

    Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories orthopedic manual instrument Arthrex Fracture System Arthrex Plates, Screws, and Staples Arthrex Distal Extremity Plate System Arthrex Ankle Fusion Plating System MINI TIGHTROPE ARTHROERESIS IMPLANT Arthrex Low Profile Screws INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT VARIOUS INSTRUMENTS Orthopedic Template Component, Traction, Non-Invasive BIOCOMPOSITE SUTURE ANCHORS ARTHROSCOPY LEG HOLDER Arthrex MicroSuture Anchors SHAVER SYSTEM smooth or threaded metallic bone fixation fastener Arthrex Tibial GraftBolt Bio-Composite SutureTak Fracture Plates & Screws Arthrex SwiveLock Anchors Arthrex PCL TightRope General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Camera Heads BIO-PIN fixation plate LOW PROFILE PLATE AND SCREW SYSTEM drill bit Metallic Bone Fixation Biosync Bone wedge Biosync SHOULDER HOLDER Apparatus, Traction, Non-Powered MALLET, SURGICAL, GENERAL & PLASTIC SURGERY COMPRESSION STAPLE DOUBLE SYRINGE (ACP) SYSTEM WASHER Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener Graft Delivery Device with Integrated Stylet OSTEOTOMY PLATE ORTHOPEDIC MANUAL INSTRUMENTS CONTINUOUS WAVE III TENODESIS FAMILY INTERFERENCE SCREWS Instrument, manual, surgical, general use Arthrex Suture Arthrex Fracture Plates Arthrex Minimally Invasive Ankle Fusion Plate RETROBUTTON BIOCOMPOSITE INTERFERENCE SCREW CORKSCREW ANCHORS VARIOUS BURS SHAVER BLADES Arthrex PushLock Dual Wave Pump Table Attachments, Operating-Room Arthroscopes Arthrex Pushlock single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes ACL TightRope PUSHLOCK OPES ELECTRODES AND ACCESSORIES RF device, blade, hook

    Establishment Types

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