BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MONDRIAN NITRO AL System

    Reg #: 3025602479 · FEI: 3025602479 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CTL BIOTEC
    Registration Number
    3025602479
    FEI Number
    3025602479
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SEONGSEO-RO 329 SUITE 410, DALSEO-GU
    City
    Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K220513

    Owner / Operator

    Firm Name
    CTL Biotec Co., Ltd.
    Operator Number
    10086812
    Address
    SEONGSEO-RO 329 SUITE 410, DALSEO-GU
    City
    Daegu
    State
    KR-NOTA
    Postal Code
    42703
    Country
    KR
    Correspondent
    Hyoin Jeon

    US Agent

    Business Name
    CTL Medical
    Contact Name
    Kayla Chott
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    ZIP
    75006
    Country
    US
    Email
    [email protected]
    Phone
    214 5455820

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP

    Proprietary Names

    MONDRIAN NITRO AL System MONDRIAN NITRO PL/TL System MATISSE/MONET NITRO ACIF System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)