BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PathLoc-SI Joint Fusion System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    97
    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
    K181600

    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
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    PathLoc-SI Joint Fusion System 1023-6055S 1022-2050S 1023-7030 1023-6050 1022-1030S 1203-0008 1022-1050S 1022-2045S 1023-7070S 1022-1035S 1023-6030S 1022-1045S 1023-8070S 1023-7060S 1023-7060 1023-8055S 1022-1070S 1022-2065S 1023-6050S 1023-8065S 1022-1060 1022-2050 1022-2055S 1022-1070 1022-1035 1023-7045 1023-7050 1022-1055 1022-2035 1023-7040 1022-2030S 1023-6065 1022-2060 1023-8030S 1023-6070 1023-7035S 1023-7065S 1203-0006 1203-0008S 1023-6070S 1023-6035 1023-8045S 1022-1040S 1022-2070 1023-7040S 1023-8035S 1203-0007S 1023-7045S 1023-7050S 1022-1030 1022-2055 1023-8035 1203-0006S 1022-2030 1023-8040S 1023-6055 1023-8070 1023-7055S 1023-6060 1022-2060S 1022-1060S 1022-1065 1022-1050 1022-2040 1023-6030 1022-2045 1022-2070S 1023-7055 1203-0007 1022-1065S 1023-6040 1023-8030 1023-8060 1023-7070 1023-8050 1023-6045S 1023-7030S 1023-8045 1022-2040S 1023-8040 1023-6040S 1022-1055S 1022-1045 1022-2035S 1023-6045 1023-6035S 1023-7035 1022-1040 1022-2065 1023-8050S 1023-8055 1023-6060S 1023-8060S 1023-6065S 1023-7065 1023-8065

    Establishment Types

    Manufacture Medical Device