BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AccelFix Lumbar Plate System

    Reg #: 3008285983 · FEI: 3008285983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    237
    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
    K192481

    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
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    AccelFix Lumbar Plate System 7302-6020 7102-5525 5215-2032S 5015-3244S 7302-6035 5015-3648S 7102-5530 7302-6035S 5015-3244 5326-3852 7102-5545 5015-2840S 7302-5545S 2426-2034 7302-6040 7101-5555S 7102-6025S 7302-6050 7302-6055S 7102-5520S 5426-2236 7302-5555S 5426-3650 7301-5520 5326-3246S 7101-6025S 7302-6030S 7302-5530 7301-6050S 7101-5545S 7302-5525S 5426-3650S 5326-3852S 5426-1832S 7102-5555 7302-5525 2426-2640 7301-6030S 7301-5545 7302-5545 7101-5535S 7302-6020S 5326-4054S 7302-5530S 5326-2438 5215-2234S 7101-6045 7101-5525 5326-3044S 5326-2034 2426-2438S 7301-5555 2426-3852 5015-2234 5015-2436S 7301-5535S 7102-5535S 7301-5520S 7301-6025S 2426-3852S 7302-5550 7301-6055S 5015-3648 7302-5535 2426-2236S 7301-6030 7302-6025 7101-6040S 7102-6030 7301-5525 7101-6050S 7102-6050 7301-5540S 5015-3042 2426-4054 7102-5555S 7102-6025 5215-2436 7301-6020 5426-3044S 7101-5550S 7301-6050 7302-6040S 5215-2638 7101-5540S 5426-3246S 5015-2436 5326-1832 7301-5540 5015-2638S 5215-3446S 5215-3244S 5015-2234S 7301-6055 7301-5535 5426-2640S 5426-2842 7301-5545S 7101-6030S 5215-3042 7302-5540S 5426-2438 5426-3044 2426-2034S 7302-6045 7302-6055 5426-3448 7302-6050S 7301-5525S 2426-2640S 7101-6020S 5015-2840 7102-6040S 7302-5550S 7302-5520S 2426-2236 7102-5550S 5326-1832S 5215-3648S 2426-3044S 5426-3246 7101-6035 7102-6050S 7101-5525S 5326-2438S 7102-6045 7301-5530S 2426-3650S 7302-6045S 7301-6020S 7101-6025 7101-6030 7101-6020 7102-5540 7302-6030 7302-5520 7302-5555 5215-2638S 5426-3852S 5426-1832 7301-6035S 5326-3246 7102-5545S 2426-3448 7301-6025 5426-2034S 7101-5550 5426-3448S 2426-3246 5426-3852 7101-5520 7102-5540S 2426-2438 7102-5530S 7101-5530S 7101-5545 7101-6055 2426-3044 7102-5525S 7101-5530 5215-2840 7102-6045S 5215-3648 7102-6020 7102-5550 5015-2032S 5326-2842S 5426-2842S 2426-3650 5015-2638 7101-6050 7301-5550S 7302-6025S 5326-2640S 5215-3446 7301-5550 7101-5540 7302-5535S 7301-6040 7301-6035 7101-6035S 5426-2640 7101-5520S 5015-3042S 2426-1832S 7102-5520 5326-3448S 5215-2234 5215-2436S 7102-6035S 5326-2236S 7102-6030S 7101-5555 5426-2236S 5326-4054 7301-5555S 2426-4054S 5326-2640 7101-6040 5326-3650 2426-2842 5215-3042S 7102-6055S 5326-2034S 5326-2842 5326-3650S 2426-1832 7301-6045 7302-5540 5326-3448 7101-6055S 5015-3446 2426-2842S 2426-3246S 5426-2438S 7301-5530 5326-3044 5215-2840S 5015-2032 5426-4054 7102-6055 5215-2032 7102-6020S 5215-3244 7102-5535 5015-3446S 5426-2034 5426-4054S 7102-6040 7102-6035 5326-2236 7101-5535 7101-6045S 7301-6040S 7301-6045S 2426-3448S

    Establishment Types

    Manufacture Medical Device