BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    4CIS VANE Spine System

    Reg #: 3004941535 · FEI: 3004941535 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALPHANOX CO., LTD.
    Registration Number
    3004941535
    FEI Number
    3004941535
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    154, Seotan-ro, Seotan-myeon
    City
    PYEONGTAEK Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K060702

    Owner / Operator

    Firm Name
    ALPHANOX CO., LTD
    Operator Number
    9036105
    Address
    154, Seotan-ro, Seotan-myeon, --
    City
    PYEONGTAEK
    State
    Gyeonggi
    Postal Code
    17704
    Country
    KR

    US Agent

    Business Name
    SOLCO BIOMEDICAL CORPORATION
    Contact Name
    Cindy Lee
    Address
    4100 Midway Rd Ste 1130
    City
    Carrollton
    State
    TX
    ZIP
    75007
    Country
    US
    Email
    [email protected]
    Phone
    972 2472486

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    4CIS VANE Spine System

    Establishment Types

    Manufacture Medical Device