BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PathLoc-L MIS Spinal System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    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
    K112643

    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
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    PathLoc-L MIS Spinal System LnK MIS Spinal System

    Establishment Types

    Manufacture Medical Device