BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PathLoc-L MIS Spinal System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    704
    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
    K183117

    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
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    PathLoc-L MIS Spinal System LnK MIS Spinal System 2607-6560S 2631-7550S 2611-6535S 2624-6555S 2605-7555S 2631-5530S 2630-5545S 2612-7540S 2632-5535S 2631-7560S 2607-5545S 2632-6555S 2516-6065S 2606-6550S 2609-7545S 2610-6560S 2510-55400S 2631-7540S 2632-6545S 2626-7535S 2727-5535S 2611-5535S 2629-7545S 2624-7560S 2625-6535S 2728-7555S 2628-7530S 2516-60300S 2627-6550S 2729-5545S 2612-7535S 2730-6545S 2510-5585S 2627-7550S 2732-7540S 2604-6545S 2724-5530S 2604-5560S 2612-5530S 2728-6545S 2624-7545S 2611-6550S 2726-6545S 2520-5575S 2629-5545S 2729-6560S 2732-7560S 2628-5560S 2610-5560S 2510-55150S 2627-5550S 2610-6530S 2611-7545S 2726-7555S 2625-6555S 2725-5540S 2516-60110S 2612-5555S 2631-5535S 2731-7545S 2606-6545S 2510-55170S 2516-60190S 2612-7555S 2612-5540S 2628-7545S 2606-6555S 2726-6535S 2730-5530S 2516-6090S 2630-6550S 2725-7560S 2606-5545S 2609-6560S 2628-5545S 2611-5560S 2632-7530S 2516-6095S 2628-7550S 2520-5585S 2724-6530S 2728-5545S 2624-6560S 2516-6055S 2732-5530S 2712-7535S 2611-7555S 2625-5555S 2607-6545S 2626-6530S 2609-5550S 2516-60170S 2730-5545S 2732-5535S 2625-7560S 2728-7535S 2726-5530S 2627-6560S 2631-7535S 2725-5555S 2607-6555S 2516-60500S 2520-5590S 2605-6555S 2516-60260S 2632-6540S 2631-7555S 2607-7550S 2520-5595S 2727-7530S 2609-6545S 2510-55240S 2624-5545S 2731-7550S 2728-6550S 2510-55130S 2725-7535S 2726-5555S 2510-55140S 2632-7535S 2631-7545S 2731-6530S 2629-6535S 2630-6545S 2630-5550S 2731-6540S 2520-5535S 2626-5530S 2626-6555S 2724-7545S 2629-7530S 2626-7550S 2629-5530S 2726-6555S 2724-6555S 2626-5545S 2631-5545S 2516-6085S 2625-7535S 2728-6530S 2727-7550S 2608-6555S 2729-6545S 2628-6530S 2624-6540S 2632-7540S 2725-7540S 2725-5535S 2627-5560S 2606-5560S 2510-5570S 2627-7560S 2726-7545S 2610-7530S 2726-6560S 2605-5540S 2726-5560S 2732-5560S 2611-7540S 2626-5535S 2625-7545S 2605-5555S 2605-6560S 2626-7530S 2609-5555S 2631-7530S 2729-7535S 2727-7555S 2516-60600S 2629-7560S 2726-6530S 2611-7550S 2725-5550S 2632-6560S 2606-7555S 2727-6535S 2606-7530S 2629-6550S 2712-6550S 2611-6530S 2628-7555S 2729-7550S 2732-5545S 2726-7540S 2612-7550S 2727-5555S 2731-7535S 2516-60280S 2610-5535S 2630-5540S 2730-5535S 2610-5540S 2630-5555S 2510-55290S 2726-6550S 2727-7535S 2607-5555S 2606-6540S 2724-7540S 2609-6550S 2516-6075S 2610-5545S 2510-5575S 2628-5550S 2627-5545S 2628-6540S 2612-6545S 2629-7555S 2628-5540S 2629-6555S 2516-60550S 2516-60400S 2611-6545S 2516-6060S 2516-60230S 2728-7540S 2608-5560S 2526-60100S 2726-5545S 2627-6535S 2625-6560S 2609-5545S 2608-6530S 2627-6545S 2724-6545S 2606-7540S 2526-6080S 2516-60210S 2726-7530S 2606-7545S 1308-0000S 2730-5550S 2605-7540S 2516-60120S 2510-5540S 2732-6560S 2628-6545S 2631-5555S 2520-55120S 2510-55230S 2520-5580S 2727-5560S 2732-5540S 2605-7550S 2712-7555S 2510-55500S 2627-5530S 2732-6555S 2604-7545S 2624-6545S 2611-5550S 2729-7530S 2731-6555S 2729-6555S 2607-7545S 2732-7545S 2604-6550S 2510-55260S 2608-6560S 2712-6545S 2607-7535S 2730-6560S 2631-6530S 2628-5530S 2606-7535S 2724-5545S 2610-7555S 2510-55160S 2610-7560S 2627-7545S 2629-6530S 2627-5555S 2516-60200S 2605-6540S 2626-6535S 2608-7550S 2605-7530S 2627-5535S 2608-5555S 2605-7560S 2728-7530S 2724-5550S 2516-60100S 2604-6530S 1307-0000S 2730-7535S 2612-7545S 2611-6560S 2608-7540S 2625-6540S 2712-7530S 2630-6555S 2609-5530S 2627-5540S 2610-6550S 2606-5555S 2526-6085S 2526-60140S 2604-6540S 2712-7545S 2625-5560S 2732-7550S 2612-5545S 2724-7550S 2630-6535S 2729-5535S 2516-6080S 2724-6560S 2632-5560S 2510-55210S 2520-5560S 2516-6070S 2631-5550S 2526-60130S 2726-7550S 2631-6550S 2630-7560S 2516-60150S 2520-5545S 2624-7555S 2526-6045S 2607-5550S 2727-6560S 2516-60290S 2726-5540S 2626-5555S 2712-7560S 2611-5555S 2724-5560S 2605-5545S 2607-7555S 2516-60160S 2612-6555S 2627-6555S 2604-5555S 2604-5550S 2610-5550S 2728-6540S 2630-5560S 2724-5535S 2626-5540S 2609-7535S 2510-5580S 2629-7540S 2632-7560S 2632-5530S 2516-6040S 2510-55120S 2610-5555S 2526-6040S 2729-5540S 2612-7560S 2604-5530S 2526-6095S 2624-5560S 2628-7560S 2727-7540S 2725-7545S 2609-5540S 2728-6535S 2730-5555S 2510-55550S 2604-5535S 2626-7555S 2731-5550S 2510-55270S 2510-55200S 2728-6555S 2612-6560S 2625-7540S 2605-6535S 2607-6530S 2727-6540S 2625-5540S 2630-7555S 2609-7540S 2628-6560S 2730-7555S 2606-5530S 2604-7550S 2510-55180S 2627-7540S 2605-5530S 2625-7550S 2604-6555S 2510-55190S 2606-6535S 2731-6550S 2605-6550S 2729-7540S 2729-6540S 2732-6530S 2609-7560S 2727-5550S 2725-6560S 2608-6545S 2526-6055S 2632-6550S 2510-5565S 2516-60180S 2631-6560S 2726-6540S 2732-6550S 2612-5550S 2526-6075S 2727-7560S 2729-6535S 2516-6035S 2625-5530S 2611-7535S 2625-5535S 2632-5555S 2510-5555S 2630-6560S 2728-5535S 2624-5530S 2729-5530S 2510-5550S 2604-5540S 2624-5540S 2724-7535S 2625-6545S 2610-7550S 2712-6560S 2629-5540S 2607-7540S 2626-6560S 2727-5540S 2608-6535S 2630-6530S 2628-7535S 2724-7530S 2607-5530S 2732-5555S 2730-6555S 2516-60130S 2730-7560S 2516-60450S 2516-60140S 2610-6545S 2604-7540S 2728-6560S 2625-6530S 2712-6555S 2731-6545S 2730-7540S 2724-7560S 2732-7555S 2526-6070S 2728-7550S 2607-7530S 2729-6530S 2729-7555S 2731-5555S 2729-5555S 2612-5535S 2729-5560S 2726-5550S 2725-6555S 2606-5540S 2727-6555S 2526-60150S 2725-6540S 2624-7535S 2725-7550S 2731-5560S 2608-5550S 2731-5545S 2606-6530S 2510-55220S 2632-5545S 2729-7545S 2609-7550S 2606-5535S 2731-7530S 2516-60220S 2732-6545S 2608-7555S 2516-60250S 2624-5550S 2608-6540S 2724-5555S 2608-5535S 2626-6545S 2628-5535S 2629-6560S 2610-7535S 2629-6545S 2510-55450S 2607-7560S 2606-7560S 2724-6540S 2632-5540S 2724-6535S 2631-6555S 2628-6535S 2510-55350S 2605-6545S 2730-6550S 2607-6535S 2610-6555S 2630-7530S 2624-7550S 1306-0000S 2626-7540S 2625-6550S 2510-55300S 2730-7530S 2608-7545S 2510-55110S 2526-6090S 2611-6555S 2630-7535S 2727-7545S 2608-7530S 2628-7540S 2510-5545S 2626-5560S 2727-6530S 2605-7535S 2725-6550S 2606-6560S 2724-7555S 2510-55250S 2632-6535S 2520-55150S 2604-5545S 2631-5560S 2725-6545S 2712-7550S 2608-7560S 2726-7535S 2724-6550S 2526-6050S 2605-5560S 2731-6535S 2732-6540S 2608-5540S 2606-5550S 2510-55280S 2628-6550S 2607-5540S 2612-6530S 2712-6535S 2609-6535S 2611-5540S 2727-6550S 2631-6545S 2605-6530S 2725-7555S 2520-5540S 2730-5560S 2605-7545S 2624-5535S 2731-7540S 2610-5530S 2728-7560S 2631-6535S 2510-5595S 2609-7530S 2609-6530S 2516-60350S 2627-7530S 2632-5550S 2610-7540S 2731-7555S 2624-6530S 2732-7535S 2727-6545S 2629-7535S 2611-7530S 2604-7560S 2624-7540S 2510-5560S 2611-7560S 1302-0000S 2520-55100S 2732-6535S 2632-7550S 2605-5550S 2732-7530S 2608-5545S 2520-55110S 2626-5550S 2624-5555S 2627-6540S 2626-6540S 2730-6530S 2607-6550S 2608-5530S 2725-6530S 2526-60110S 2730-7550S 2612-6550S 2625-7555S 2632-7555S 2520-5570S 2728-5530S 2630-6540S 2730-6535S 2626-6550S 2627-7555S 2625-5545S 2629-5560S 2630-5530S 2510-55600S 2630-7545S 2526-6060S 2610-7545S 2630-7550S 2731-5535S 2604-6535S 2728-5540S 2725-6535S 2630-7540S 2729-5550S 2604-7530S 2604-7555S 2526-6035S 2520-55140S 2526-6065S 2610-6540S 2606-7550S 2627-6530S 2731-7560S 2609-5535S 2712-7540S 2725-5560S 2612-6540S 2516-6045S 2730-7545S 2629-5535S 2731-5540S 2728-7545S 2624-6535S 2632-6530S 2612-5560S 2728-5550S 2609-7555S 2629-5555S 2608-7535S 2609-6555S 2510-55100S 2724-5540S 2729-7560S 2609-6540S 2516-6050S 2624-7530S 2726-5535S 2627-7535S 2628-6555S 2727-5530S 2520-55130S 2626-7545S 2630-5535S 2526-60120S 2611-5545S 2725-5545S 2712-6540S 2516-60270S 2730-5540S 2520-5550S 2612-7530S 2607-5560S 2625-5550S 2731-5530S 2629-5550S 2612-6535S 2629-6540S 2607-5535S 2625-7530S 2729-6550S 2728-5560S 2611-5530S 2609-5560S 2510-5590S 2631-5540S 2632-7545S 2605-5535S 2608-6550S 2725-5530S 2611-6540S 2604-7535S 2731-6560S 2727-5545S 2629-7550S 2610-6535S 2520-5565S 2725-7530S 2732-5550S 2510-5535S 2628-5555S 2607-6540S 2520-5555S 2626-7560S 2631-6540S 2728-5555S 2726-7560S 2624-6550S 2516-60240S 2604-6560S 2730-6540S

    Establishment Types

    Manufacture Medical Device