BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TranS1 Anterior Cervical Plate System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    113
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    L&K BIOMED CO.,LTD.
    Registration Number
    3008285983
    FEI Number
    3008285983
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #101, 201, #202, 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu
    City
    Yongin-SI Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K143279

    Owner / Operator

    Firm Name
    L&K BIOMED CO., LTD.
    Operator Number
    10033804
    Address
    #101, 201, 202, 16-25, Dongbaekjungang-ro,, 16 beon-gil, Giheung-gu
    City
    Youngin-si
    State
    Gyeonggi
    Postal Code
    17015
    Country
    KR
    Correspondent
    Kihyang Kim

    US Agent

    Business Name
    ComplianceAcuity, Inc
    Contact Name
    Kevin Randall
    Address
    485 Clinton St, #888
    City
    Ridgeway
    State
    CO
    ZIP
    81432
    Country
    US
    Email
    [email protected]
    Phone
    303 8280844

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    TranS1 Anterior Cervical Plate System LnK Anterior Cervical Plate System 6512-1749 6513-1751 6504-3519 6503-4015 6513-1766 6514-1769 6511-1725 6511-1727 6511-1733 6504-4012 6512-1737 6502-4014 6514-1789 6502-4019 6511-1721 6502-3517 6502-4013 6512-1751 6502-3520 6502-3516 6503-3514 6502-3513 6501-3518 6504-3520 6503-3516 6513-1760 6511-1719 6504-3515 6503-4019 6504-4013 6501-4015 6504-4019 6504-4014 6512-1739 6503-4017 6511-1731 6503-3515 6513-1763 6501-3513 6503-3519 6514-1773 6501-4016 6513-1748 6501-4012 6502-4018 6501-3516 6501-3520 6501-3514 6514-1777 6503-4016 6501-4017 6504-3512 6504-4016 6503-3518 6514-1797 6502-3512 6504-4015 6503-3512 6512-1735 6513-1769 6502-4016 6504-4017 6513-1757 6502-3519 6503-4012 6514-1793 6503-4014 6501-3515 6502-3514 6511-1735 6501-4013 6511-1723 6502-4012 6511-1713 6511-1717 6501-4014 6503-4020 6501-4019 6514-1785 6504-3514 6504-4018 6504-3517 6512-1747 6512-1741 6502-3515 6512-1745 6501-3512 6514-1781 6501-4018 6513-1772 6503-3513 6504-3513 6511-1729 6501-3519 6502-4020 6504-3516 6513-1754 6502-4017 6504-3518 6503-4018 6503-3517 6501-4020 6511-1715 6512-1743 6503-4013 6504-4020 6502-4015 6514-1765 6501-3517 6503-3520 6502-3518

    Establishment Types

    Manufacture Medical Device