BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology

    Reg #: 3014252644 · FEI: 3014252644 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    C&A Tool Engineering, Inc. Auburn Plant
    Registration Number
    3014252644
    FEI Number
    3014252644
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1015 W 15th St
    City
    Auburn
    State
    IN
    ZIP
    46706
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171689

    Owner / Operator

    Firm Name
    MinebeaMitsumi Inc.
    Operator Number
    10055758
    Address
    3-9-6 Mita
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    108-8330
    Country
    JP

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology ARTiC-L™ Spinal System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)