BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ARTHREX GMBH

    Reg #: 3007193505 · FEI: 3007193505 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    16

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    Registration Details

    Registration Name
    ARTHREX GMBH
    Registration Number
    3007193505
    FEI Number
    3007193505
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Oskar-von-Miller Strasse 6
    City
    Odelzhausen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180594

    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
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bit, Drill HTW
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Instrument, Manual, Surgical, General Use MDM
    Orthopedic Manual Surgical Instrument LXH
    Bur, Surgical, General & Plastic Surgery GFF
    Syringe, Piston FMF
    Camera, Cine, Endoscopic, Without Audio FWL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Gauge, Depth HTJ
    Accessories, Arthroscopic NBH
    Filler, Bone Void, Calcium Compound MQV
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Camera, Surgical And Accessories KQM

    Proprietary Names

    SHAVER BLADES drill bit Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS VARIOUS BURS DOUBLE SYRINGE (ACP) SYSTEM CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT orthopedic manual instrument VARIOUS INSTRUMENTS HATRIC ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P Camera Heads

    Establishment Types

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