BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PT2511-1212S

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    72
    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
    K213441

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    PT2511-1212S PT2211-1000S PT2511-1008S PT2211-1020 PT2511-1004 PT2211-1208 PT2211-1200 PathLoc Lumbar Interbody Fusion Cage System PT2511-1220 PT2211-1015 PT2511-1215S PT2511-1212 PT2511-1220S PT2511-0815S PT2211-0800S PT2511-0820 PT2511-0800 PT2511-0812S PT2511-0804 PT2511-1020S PT2511-1215 PT2511-1204 PT2511-1020 PT2211-1215S PT2211-1004 PT2211-1200S PT2211-1004S PT2511-1012S PT2211-1215 PT2211-1220 PT2511-1200 PT2211-1208S PT2511-1012 PT2211-0820S PT2211-1012S PT2211-0804 PT2211-0815S PT2211-1008 PT2511-0808 PT2511-1008 PT2511-0812 PT2511-1208 PT2211-1204 PT2211-0808 PT2211-0820 PT2211-0812 PT2511-0815 PT2511-0804S PT2211-0812S PT2511-1208S PT2211-1008S PT2211-1000 PT2211-1220S PT2211-1212 PT2511-0808S PT2211-1012 PT2511-1000 PT2211-0815 PT2511-1000S PT2211-1020S PT2511-1204S PT2211-0804S PT2211-1204S PT2511-0800S PT2511-1015S PT2211-0808S PT2211-1212S PT2211-1015S PT2511-0820S PT2511-1015 PT2511-1200S PT2511-1004S

    Establishment Types

    Manufacture Medical Device