BEUDAMED
    FDA Registration Active 🇺🇸 United States

    fixation plate

    Reg #: 3015231789 · FEI: 3015231789 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Arthrex Manufacturing Inc.
    Registration Number
    3015231789
    FEI Number
    3015231789
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    130 Arthrex Drive
    City
    Pendleton
    State
    SC
    ZIP
    29670
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052614

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    fixation plate LOW PROFILE PLATE AND SCREW SYSTEM

    Establishment Types

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