BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arthrex Logistic Center

    Reg #: 3009423112 · FEI: 3009423112 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    31

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    Registration Details

    Registration Name
    Arthrex Logistic Center
    Registration Number
    3009423112
    FEI Number
    3009423112
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14550 Plantation Road
    City
    Fort Myers
    State
    FL
    ZIP
    33912
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121124

    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
    Syringe, Piston FMF
    Shoulder Prosthesis, Reverse Configuration PHX
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Pin, Fixation, Smooth HTY
    Gauge, Depth HTJ
    Instrument, Biopsy KNW
    Camera, Cine, Endoscopic, Without Audio FWL
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Bit, Drill HTW
    Staple Driver HXJ
    Staple, Fixation, Bone JDR
    Suture, Nonabsorbable, Silk GAP
    Arthroscope HRX
    Forceps HTD
    Needle, Suturing, Disposable GAB
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Support, Patient Position CCX
    Balance, Analytical JQO
    Washer, Bolt Nut HTN
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Manual Surgical Instrument LXH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Surgical, General & Plastic Surgery GFF
    Prosthesis, Toe, Hemi-, Phalangeal KWD

    Proprietary Names

    Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System orthopedic manual instrument CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO Arthrex Low Profile Screws Arthrex Univers II Shoulder Prosthesis drill bit ACL TightRope RETROBUTTON Syringe, piston Arthroscope Sheath PARS Needle OPES ELECTRODES AND ACCESSORIES RF device, blade, hook Arthrex PCL TightRope SUPPORT, PATIENT POSITION Balance, Analytical UNIVERS FRACTURE HUMERAL FRACTURE PLATE WASHER fixation plate LOW PROFILE PLATE AND SCREW SYSTEM Arthrex Distal Extremity Plate System Instrument, manual, surgical, general use INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT ORTHOPEDIC MANUAL INSTRUMENTS UNIVERS II MENISCAL CINCH SHAVER BLADES VARIOUS BURS Mini TightRope CMC Arthroscope ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P UNIVERS SHOULDER Arthrex Suture Arthrex Univers II Glenoid Components

    Establishment Types

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