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Medical DevicesKOSDAQ 156100169 approvals

L&K BIOMED CO., LTD.

Official website

Spinal implant device maker founded 2008, listed on KOSDAQ 2016; produces Cervical and Thoraco Lumbar Cage, Screw, and Plate products.

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Market cap

Business overview

Source: DART corporate disclosure

L&K BIOMED CO., LTD. was founded in 2008 and listed on KOSDAQ in 2016 as a medical device company specializing in spinal implants, designing, developing, manufacturing, and selling spinal fixation devices and spinal surgery products for orthopedics and neurosurgery. Products are classified by site into Cervical and Thoraco Lumbar types, and by surgical use into Cage, Screw, and Plate, all as Class III medical devices. It signed a technology transfer agreement with AEGIS SPINE, INC. in December 2022 for the Anterior Expandable Cage System (total value $260,000), and subsidiary L&K SPINE, INC. acquired Aegis Meditech, Inc.'s Spine division hospital registration rights in December 2025 for USD 3,972,606.

Products & technology

  • Cervical spinal implantsUsed in neurosurgery to treat conditions of the cervical spine
  • Thoraco Lumbar spinal implantsUsed in orthopedics to treat spinal instability from degeneration, stenosis, external trauma, or tumors, and for spinal deformity and scoliosis treatment
  • Cage / Screw / PlateSpinal implant product classification by surgical use

Regulatory approvals

data.go.kr · openFDA

112 Korean MFDS device approvals · 2002–2026 / 57 US FDA 510(k) · 2010–2026

  • MFDSSpinal cage2026-06-18
    Product approval · Class 3제허 26-461 호
  • FDABluEX Cervical Expandable Cage System2026-05-16
    510(k) · TraditionalOrthopedicK260840
  • FDACastleLoc-P Anterior Cervical Plate System2026-05-06
    510(k) · SpecialOrthopedicK261112
  • FDAAccelFix Spinal Fixation System2026-05-05
    510(k) · SpecialOrthopedicK261130
  • MFDSSpinal cage2026-04-29
    Product approval · Class 3제허 26-321 호
  • MFDSSpinal internal fixation system, intervertebral bodyRevoked2026-04-29
    Product approval · Class 3제허 26-320 호
  • FDACastleLoc Pectus Bar System2026-03-19
    510(k) · SpecialOrthopedicK260448
  • FDAPathLoc Lumbar Plate System2026-03-03
    510(k) · TraditionalOrthopedicK251940
  • MFDSSpinal cageRevoked2025-07-25
    Product approval · Class 3제허 25-513 호
  • FDAPathLoc Lumbar Interbody Fusion Cage System2025-07-08
    510(k) · SpecialOrthopedicK251741
  • MFDSOrthopaedic fixation plate kit, non-biodegradable2025-06-24
    Product approval · Class 3제허 25-407 호
  • MFDSSpinal internal fixation system, intervertebral body2025-05-20
    Product approval · Class 3제허 25-335 호
Show 68 more
  • MFDSSpinal internal fixation system, intervertebral body2025-05-20
    Product approval · Class 3제허 25-334 호
  • MFDSClamp, manually-operated, reusable2025-05-08
    Product approval · Class 1제신 25-593 호
  • FDACastleLoc Pectus Bar System2025-04-25
    510(k) · SpecialOrthopedicK250892
  • MFDSMeasuring instrument, general-purpose2025-04-07
    Product approval · Class 1제신 25-424 호
  • FDACastleLoc Pectus Bar System2025-02-27
    510(k) · TraditionalOrthopedicK243357
  • MFDSOrthopaedic fixation plate kit, non-biodegradableRevoked2024-11-13
    Product approval · Class 3제허 24-801 호
  • MFDSSpinal cageRevoked2024-11-11
    Product approval · Class 3제허 24-778 호
  • FDABluEX Lumbar Expandable Cage System2024-10-23
    510(k) · TraditionalOrthopedicK242829
  • MFDSInstruments, bone, surgical, manually-operated2024-10-15
    Product approval · Class 1제신 24-1253 호
  • MFDSSizer for medical or dental use2024-09-30
    Product approval · Class 1제신 24-1199 호
  • MFDSTissue dissector, reusable2024-09-27
    Product approval · Class 1제신 24-1196 호
  • MFDSGuide for medical use2024-09-26
    Product approval · Class 1제신 24-1191 호
  • FDAPathLoc SI Joint Fusion System2024-02-23
    510(k) · SpecialOrthopedicK240201
  • MFDSChisel, surgical, manually-operated2024-02-19
    Product approval · Class 1제신 24-208 호
  • FDAAccelFix Lumbar Expandable Cage System2023-08-24
    510(k) · SpecialOrthopedicK231680
  • MFDSMeasuring instrument, general-purpose2023-08-22
    Product approval · Class 1제신 23-1262 호
  • FDALnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System2023-08-14
    510(k) · SpecialOrthopedicK232311
  • FDACastleLoc-S Posterior Cervical Fixation System2023-07-20
    510(k) · SpecialOrthopedicK231840
  • FDACastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System2023-07-19
    510(k) · SpecialOrthopedicK231839
  • FDAPathLoc SI Joint Fusion System2023-07-14
    510(k) · SpecialOrthopedicK231841
  • FDALnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.2023-06-27
    510(k) · SpecialOrthopedicK231636
  • FDALnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System2023-02-28
    510(k) · SpecialOrthopedicK230245
  • MFDSSpinal internal fixation system, intervertebral body2023-02-14
    Product approval · Class 3제허 23-98 호
  • MFDSInstruments, bone, surgical, manually-operated2023-01-20
    Product approval · Class 1수신 23-126 호
  • FDAPathLoc-TA Expandable Lumbar Cage System2023-01-13
    510(k) · TraditionalOrthopedicK223474
  • MFDSDilator, general-purpose2023-01-03
    Product approval · Class 1제신 23-3 호
  • MFDSGuide for medical use2023-01-02
    Product approval · Class 1제신 23-2 호
  • FDALnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.2022-12-23
    510(k) · SpecialOrthopedicK223565
  • MFDSElevator, surgical, manually-operated2022-12-01
    Product approval · Class 1제신 22-1699 호
  • MFDSRetractor, surgical, manually-operated2022-11-24
    Product approval · Class 1제신 22-1661 호
  • MFDSSizer for medical or dental use2022-11-23
    Product approval · Class 1제신 22-1657 호
  • MFDSPuncture instrument, surgical, manually-operated, reusable2022-11-18
    Product approval · Class 1제신 22-1634 호
  • MFDSHammer, surgical, manually-operated2022-11-16
    Product approval · Class 1제신 22-1619 호
  • MFDSForceps, bone2022-11-15
    Product approval · Class 1제신 22-1609 호
  • MFDSRasp, surgical, bone, manually-operated2022-11-14
    Product approval · Class 1제신 22-1606 호
  • MFDSCurette, manually-operated, reusable2022-11-14
    Product approval · Class 1제신 22-1604 호
  • MFDSInstruments, bone, surgical, manually-operated2022-11-10
    Product approval · Class 1제신 22-1583 호
  • MFDSSurgical drill handpiece, manual2022-11-07
    Product approval · Class 1제신 22-1546 호
  • MFDSSpinal internal fixation system, intervertebral body2022-11-02
    Product approval · Class 3제허 22-734 호
  • MFDSSpinal internal fixation system, intervertebral body2022-11-02
    Product approval · Class 3제허 22-733 호
  • MFDSSpinal cageRevoked2022-09-22
    Product approval · Class 3제허 22-632 호
  • MFDSInstruments, bone, surgical, manually-operated2022-09-02
    Product approval · Class 1수신 22-1509 호
  • MFDSSpinal cage2022-07-22
    Product approval · Class 3제허 22-480 호
  • FDAPathLoc Lumbar Interbody Fusion Cage System2022-03-09
    510(k) · TraditionalOrthopedicK213441
  • MFDSRetractor, surgical, manually-operated2021-08-13
    Product approval · Class 1수신 21-1561 호
  • MFDSMeasuring instrument, general-purpose2021-08-12
    Product approval · Class 1수신 21-1547 호
  • MFDSInstruments, bone, surgical, manually-operated2021-08-05
    Product approval · Class 1수신 21-1497 호
  • MFDSGuide for medical use2021-08-05
    Product approval · Class 1수신 21-1492 호
  • MFDSInstruments, bone, surgical, manually-operated2021-08-03
    Product approval · Class 1수신 21-1472 호
  • MFDSSpinal internal fixation system, intervertebral body2020-12-07
    Product approval · Class 3제허 20-1050 호
  • FDALnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System2020-12-04
    510(k) · SpecialOrthopedicK200789
  • FDALnK Spinal Fixation System, OpenLoc-L Spinal Fixation System2020-10-28
    510(k) · SpecialOrthopedicK200790
  • MFDSOrthopaedic bone screw, non-biodegradable2020-10-26
    Product approval · Class 3제허 20-907 호
  • FDAAccelFix Spinal Fixation System2020-10-20
    510(k) · SpecialOrthopedicK200794
  • FDALnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System2020-10-08
    510(k) · SpecialOrthopedicK200793
  • MFDSSpinal internal fixation system, intervertebral bodyRevoked2020-08-10
    Product approval · Class 3제허 20-641 호
  • MFDSSpinal internal fixation system, intervertebral bodyRevoked2020-08-10
    Product approval · Class 3제허 20-636 호
  • FDAAccelFix Lumbar Plate System2020-07-28
    510(k) · TraditionalOrthopedicK192481
  • MFDSPuncture instrument, surgical, manually-operated, reusable2020-01-06
    Product approval · Class 1제신 20-18 호
  • MFDSInstruments, bone, surgical, manually-operated2019-12-27
    Product approval · Class 1제신 19-1744 호
  • MFDSCurette, manually-operated, reusable2019-12-23
    Product approval · Class 1제신 19-1719 호
  • FDAAccelFix Lumbar Interbody Fusion Cage System2019-09-16
    510(k) · TraditionalOrthopedicK190708
  • MFDSInstruments, bone, surgical, manually-operated2019-09-11
    Product approval · Class 1제신 19-1203 호
  • MFDSInstruments, bone, surgical, manually-operated2019-09-09
    Product approval · Class 1제신 19-1200 호
  • MFDSInstruments, bone, surgical, manually-operated2019-09-09
    Product approval · Class 1제신 19-1199 호
  • MFDSSpinal cage2019-09-04
    Product approval · Class 3제허 19-573 호
  • MFDSSpinal cage2019-09-04
    Product approval · Class 3제허 19-572 호
  • MFDSInstruments, bone, surgical, manually-operated2019-08-27
    Product approval · Class 1제신 19-1148 호

Showing the 80 most recent of 169 records.

R&D and key agreements

Source: DART corporate disclosure

Anterior Expandable Cage System (전방 척추 유합술용 높이 확장형 추간체유합보형재) · 전방 척추 유합술 · 제품화 진행 중 · In-licensed from AEGIS SPINE, INC. (signed 2022-12-27, total contract value $260,000, fully paid)

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

Alpha AI Co.,Ltd.30 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

CG MedTech Co.,Ltd.24 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

MEDYSSEY CO.,LTD23 shared

Manufactures spinal implants and metal 3D-printed patient-specific implants, exporting to over 25 countries.

Corentec Co., Ltd.21 shared

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

OSTEONIC Co., Ltd.18 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

JMT CO.,Ltd.14 shared

Provides EMS and SMT manufacturing services for TFT-LCD and OLED panel driver PBAs.

Organ Eco Tech Co.,Ltd.14 shared

Organ Eco Tech, founded in 2006 and KONEX-listed in 2016, manufactures spinal implants.

SHINHUNG CO.,LTD14 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

RootLoc Co., Ltd.9 shared

Founded in 2014 and listed on KONEX in 2020, RootLoc manufactures artificial knee joints and spinal implants for orthopedic surgery.

CELLUMED CO., LTD.8 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

DENTIS CO.,LTD8 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

WSI Co., Ltd.6 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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