BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AccelFix Spinal Fixation System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    675
    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
    K200794

    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
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    AccelFix Spinal Fixation System 1844-5765S 1387-9560 1381-15110S 1381-80110S 1385-8570 1381-1060 1386-15110 1384-9580 1385-85100S 1387-9070 1387-8560 1383-9070 1386-1080 1382-9560S 1840-6265S 1846-5762 1387-9570 1384-8590S 1386-8060 1386-90110 1382-95110 1387-8590 1387-8060 1843-5765S 1381-1080S 1387-8580 1383-8580S 1382-9080 1384-1560 1382-9060 1381-8590S 1849-5762 1382-9070 1842-6565S 1383-1590S 1381-90100S 1384-8090 1382-1560S 1385-9080S 1384-9060 1386-85110S 1382-15100 1387-90100S 1844-5762S 1840-6262 1849-6565 1843-5757S 1383-1560 1840-6565 1380-1090 1380-9090S 1386-1060S 1385-85110S 1387-90100 1380-1590 1387-8090S 1381-9590 1386-8590 1382-1570 1382-1080S 1383-9560 1383-8590S 1384-9570 1380-1060S 1843-5765 1383-1060 1381-95110S 1384-90110S 1387-1590S 1381-9080S 1387-9090S 1380-1060 1384-1590 1384-9090 1385-8060S 1384-9570S 1384-1560S 1385-15100 1387-8070 1384-8060 1387-1070S 1385-1570 1380-1560S 1384-10100S 1381-1590S 1385-8070S 1842-5757S 1386-15110S 1385-95110S 1381-8070 1383-85110 1384-85100S 1841-5762S 1386-9570S 1383-8560S 1384-8560 1380-9560 1842-6265S 1384-8570 1382-8590 1385-8090 1385-90100 1386-8580 1386-80110S 1845-5765S 1310-0000S 1380-8080S 1380-15110S 1382-15100S 1385-10100S 1387-85110S 1386-1570S 1387-8080 1386-1580 1387-85100S 1386-80110 1381-8570 1381-95100S 1381-8570S 1387-15100S 1380-8560 1382-1560 1382-9590 1380-85110 1844-6262S 1841-5765S 1386-9070 1849-6265S 1384-1570S 1842-6565 1386-90110S 1380-80100 1386-95110 1381-85100 1385-1090S 1386-85100 1382-90110S 1386-1560 1381-1580S 1386-8570S 1382-95100S 1387-8070S 1382-1090S 1383-9560S 1381-1570S 1386-9060 1385-1080 1381-95100 1385-1580S 1846-5757 1382-1070S 1383-8590 1381-8070S 1383-1060S 1845-5757 1385-9070S 1384-90100S 1381-9070S 1387-9580S 1844-5757S 1380-8590S 1387-95110S 1386-9590 1382-9570 1387-80100S 1386-10110 1380-1080S 1386-85110 1380-90100 1382-8590S 1844-6565S 1386-8090S 1386-8590S 1384-1580 1381-10110 1381-85100S 1383-8070 1843-5762 1844-6265S 1382-1570S 1842-6262S 1383-1070S 1386-9090S 1383-9080 1382-10100S 1381-1070 1380-9080S 1387-9080 1383-9590S 1383-1090 1846-5765S 1845-6262 1386-8560 1380-10100 1384-90110 1381-9570S 1384-8070S 1383-8060 1849-5765S 1385-1560S 1380-9070 1840-5765S 1849-6262 1844-5757 1380-95100 1387-95100 1382-8070S 1380-10110S 1385-8570S 1382-8090 1383-1080S 1380-8060S 1380-9560S 1381-10100 1384-9580S 1381-80100S 1386-1060 1843-6262S 1387-8090 1382-1580S 1387-15110 1383-9580 1387-10100S 1387-90110S 1842-5762S 1386-8070 1385-9560 1385-80110S 1383-1580S 1386-1590S 1382-9070S 1381-85110S 1845-6565S 1386-9070S 1386-1090 1385-9060 1387-9060 1840-6262S 1385-9570 1387-80110 1385-15110 1380-95110S 1380-9060S 1385-1580 1849-6565S 1381-9080 1385-1060S 1841-5757S 1386-8090 1381-80100 1841-6565 1384-85100 1845-5762S 1387-10110S 1384-8090S 1385-9070 1382-9090S 1383-8080 1380-1070 1845-5757S 1386-1580S 1382-9090 1386-1570 1386-95100 1387-1570 1386-90100S 1387-8580S 1381-9560S 1845-5762 1383-90100S 1381-8090 1386-1560S 1382-1590S 1383-9090S 1842-6265 1387-8560S 1846-6565S 1844-5762 1382-85100 1387-1060 1383-9580S 1386-9080S 1387-9090 1387-1060S 1380-1570S 1385-1570S 1385-1590 1380-1560 1385-9590 1380-8090 1384-8560S 1382-8570S 1382-8060S 1381-8560 1844-5765 1384-85110 1385-9580 1385-8590 1380-8570S 1383-10100S 1382-8580S 1843-6565 1845-5765 1841-5757 1383-1590 1381-1080 1385-8080S 1387-1560S 1387-8060S 1385-8560 1380-8560S 1382-1590 1386-9080 1383-8090 1381-9060 1846-6262S 1382-15110S 1385-95100 1383-85100S 1384-8060S 1381-10100S 1386-8060S 1840-6565S 1380-9580 1386-8070S 1385-1090 1382-9060S 1380-9570 1380-8080 1849-5765 1310-0000 1382-9560 1380-15110 1382-8580 1381-90110S 1385-10110S 1384-8580S 1380-1580 1383-8090S 1385-85100 1846-5757S 1385-9580S 1384-1580S 1384-1090 1383-90110S 1387-1560 1842-6262 1387-1080 1386-1090S 1384-1070S 1386-1590 1842-5757 1383-1570S 1385-8060 1381-9090 1381-90100 1382-1580 1387-95110 1384-15110 1384-15100 1382-80100S 1383-15100S 1387-9590 1380-9590S 1387-1080S 1385-90110 1840-6265 1380-8070 1381-9070 1383-15100 1846-6265 1381-8060S 1380-8580 1384-8070 1385-8560S 1384-1590S 1386-9560S 1384-10110 1846-5762S 1385-15110S 1841-5765 1386-10100S 1383-9060S 1384-9070 1383-8560 1384-1080 1846-6565 1385-9570S 1386-95100S 1382-95100 1387-1590 1385-9560S 1380-9080 1381-9590S 1382-8080S 1386-15100 1383-95110 1385-8590S 1380-9060 1387-1580 1383-8580 1387-10110 1380-80110 1383-1080 1380-95100S 1383-9570S 1383-8570S 1381-1560 1382-8060 1382-1070 1380-15100 1382-8570 1383-1570 1387-8080S 1386-1070S 1843-6565S 1383-15110S 1849-6265 1383-85100 1385-85110 1382-90100S 1382-9580 1380-85100 1383-80110S 1381-1090S 1384-80100S 1387-1090 1383-10110 1387-90110 1381-9090S 1382-9080S 1381-1580 1385-8070 1381-1590 1386-85100S 1385-9080 1380-9590 1843-6265 1383-90100 1383-9060 1380-1070S 1382-1060S 1844-6565 1386-8570 1385-80100 1381-10110S 1380-8090S 1383-10110S 1386-9590S 1386-80100 1380-80110S 1384-1090S 1384-1570 1381-9560 1383-9080S 1384-9060S 1384-80110 1846-6262 1386-95110S 1384-9090S 1842-5765S 1384-9080 1387-9590S 1382-1060 1382-80100 1383-1090S 1385-1080S 1385-10110 1385-9060S 1380-1570 1384-9560 1387-85100 1383-85110S 1387-9070S 1383-80110 1384-8080 1385-8580 1849-6262S 1382-10100 1380-10100S 1387-8570S 1380-8060 1385-8090S 1386-8080S 1384-9080S 1384-95100S 1840-5757 1385-95100S 1381-1570 1386-1080S 1387-8590S 1380-9570S 1382-8560 1383-95100 1385-1060 1843-5757 1381-8590 1849-5762S 1380-95110 1381-8080 1382-15110 1386-10110S 1380-80100S 1385-90100S 1381-9580S 1380-1090S 1844-6265 1381-15110 1387-1070 1387-9560S 1384-95110S 1384-85110S 1382-9580S 1387-8570 1844-6262 1381-8580S 1384-95100 1382-1090 1387-15100 1385-1560 1386-80100S 1386-10100 1385-90110S 1842-5765 1383-80100S 1386-9090 1380-9090 1387-85110 1383-1580 1841-6262S 1383-9070S 1382-85110 1386-9060S 1381-80110 1387-80110S 1382-10110 1381-90110 1382-9570S 1386-15100S 1385-80110 1380-15100S 1381-9570 1387-15110S 1380-10110 1846-5765 1381-85110 1380-90100S 1380-90110 1381-9060S 1380-1590S 1385-1070 1382-8090S 1381-8090S 1386-9570 1843-6262 1840-5757S 1840-5762S 1384-80100 1845-6265S 1384-8080S 1386-9580S 1386-1070 1384-1070 1381-1060S 1382-9590S 1384-95110 1386-9560 1385-80100S 1385-10100 1384-9070S 1382-85110S 1381-1070S 1384-15110S 1380-85110S 1383-15110 1387-1090S 1381-8080S 1382-8080 1382-80110S 1382-8070 1387-95100S 1386-8580S 1840-5765 1384-8580 1385-1590S 1381-8560S 1383-8080S 1383-95110S 1385-15100S 1385-9590S 1384-90100 1846-6265S 1382-10110S 1382-1080 1380-1080 1849-5757S 1384-15100S 1383-8070S 1842-5762 1383-9570 1840-5762 1387-1580S 1381-15100S 1382-8560S 1387-9080S 1381-8580 1382-85100S 1381-15100 1380-9070S 1383-8570 1384-8570S 1385-9090 1383-8060S 1384-80110S 1381-1090 1387-9060S 1380-85100S 1385-8080 1383-10100 1382-95110S 1384-1060 1386-8560S 1843-5762S 1381-95110 1841-6265 1386-8080 1385-95110 1383-1070 1380-9580S 1383-9090 1841-6265S 1384-9590S 1384-1080S 1380-1580S 1849-5757 1384-9560S 1383-95100S 1385-9090S 1384-10110S 1843-6265S 1384-8590 1387-1570S 1380-8570 1386-9580 1380-8580S 1386-90100 1387-10100 1385-1070S 1384-9590 1383-80100 1383-90110 1382-90100 1845-6262S 1381-1560S 1382-90110 1383-1560S 1380-8590 1384-1060S 1380-8070S 1384-10100 1841-5762 1845-6565 1380-90110S 1381-8060 1845-6265 1383-9590 1381-9580 1841-6262 1385-8580S 1387-9570S 1387-80100 1387-9580 1841-6565S 1382-80110

    Establishment Types

    Manufacture Medical Device