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Medical DevicesKOSDAQ 226400209 approvals

OSTEONIC Co., Ltd.

Official website

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

As of 2026-10-11, OSTEONIC Co., Ltd. has 190 Korean MFDS device approvals, 19 US FDA clearances/approvals, 4 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Osteonic was established on March 9, 2012 and listed on the KOSDAQ market on February 22, 2018 as a medical device company. It manufactures implants in the CMF (CranioMaxilloFacial), Trauma, Sports Medicine, and Spine categories, using metal materials such as stainless steel and titanium as well as bio materials such as Peek and Biocomposite. Its products are used for fixation, replacement, and adjustment of most of the 206 bones in the human body, excluding certain bones such as the spine and hip joint.

Products & technology

  • CranioMaxilloFacial (CMF) ImplantUsed for fixation of fractured bone and osteotomy in cranial and craniomaxillofacial reconstruction
  • Trauma ImplantUsed for trauma reconstruction of the hand, foot, femur, proximal tibia, etc.
  • Sports Medicine Implant and SutureUsed to fix ligaments to bone during reconstruction of shoulder, knee, arm, and leg joints
  • Spine ImplantUsed in procedures for herniated disc and spinal stenosis

Regulatory approvals

data.go.kr · openFDA

190 Korean MFDS device approvals · 2006–2026 / 19 US FDA 510(k) · 2015–2026

  • MFDSAbrasive device2026-09-08
    Product approval · Class 1수신 26-2047 호
  • MFDSAbrasive device2026-09-02
    Product approval · Class 1수신 26-2001 호
  • MFDSChisel, surgical, manually-operated2026-07-10
    Product approval · Class 1제신 26-843 호
  • MFDSGuide for medical use2026-07-09
    Product approval · Class 1제신 26-841 호
  • MFDSEndotherapy scissors, reusable2026-07-09
    Product approval · Class 1제신 26-837 호
  • MFDSEndotherapy forceps, reusable2026-07-09
    Product approval · Class 1제신 26-835 호
  • MFDSRasp, surgical, bone, manually-operated2026-07-06
    Product approval · Class 1제신 26-829 호
  • MFDSProbe, surgical, fistula, manually-operated2026-07-06
    Product approval · Class 1제신 26-825 호
  • MFDSWire/ligature passer2026-07-06
    Product approval · Class 1제신 26-823 호
  • MFDSSurgical drill handpiece, manual2026-07-01
    Product approval · Class 1제신 26-802 호
  • MFDSGuide for medical use2026-06-25
    Product approval · Class 1제신 26-779 호
  • MFDSSuture instrument, single-use2026-05-11
    Product approval · Class 2제인 26-4417 호
Show 68 more
  • MFDSEndotherapy forceps, reusable2026-04-21
    Product approval · Class 1제신 26-469 호
  • MFDSSoft-tissue fixation devices, anchor, non-biodegradable2026-03-11
    Product approval · Class 3제허 26-189 호
  • MFDSMeasuring instrument, general-purpose2026-02-27
    Product approval · Class 1제신 26-258 호
  • FDAAster2026-02-26
    510(k) · TraditionalOrthopedicK254182
  • MFDSSpinal cage2026-02-12
    Product approval · Class 3제허 26-140 호
  • MFDSSpinal cage2026-02-05
    Product approval · Class 3제허 26-109 호
  • MFDSGuide for medical use, invasive, single use2025-12-10
    Product approval · Class 2제인 25-5155 호
  • MFDSInstruments, bone, surgical, manually-operated2025-11-17
    Product approval · Class 1제신 25-1514 호
  • MFDSSpinal cage2025-11-11
    Product approval · Class 3제허 25-762 호
  • MFDSSpinal cage2025-10-23
    Product approval · Class 3제허 25-713 호
  • MFDSGraft/prosthesis, biomaterial2025-10-21
    Product approval · Class 4제허 25-706 호
  • MFDSSpinal internal fixation system, intervertebral body2025-09-29
    Product approval · Class 3제허 25-671 호
  • MFDSDressing, adhesion barrier2025-09-11
    Product approval · Class 3제허 25-630 호
  • MFDSSurgical drill handpiece, manual2025-09-08
    Product approval · Class 1제신 25-1190 호
  • MFDSCatheter, evacuator2025-08-28
    Product approval · Class 1제신 25-1146 호
  • MFDSGuide for medical use2025-08-28
    Product approval · Class 1제신 25-1145 호
  • MFDSRetractor, surgical, manually-operated2025-08-28
    Product approval · Class 1제신 25-1144 호
  • MFDSChisel, surgical, manually-operated2025-08-28
    Product approval · Class 1제신 25-1138 호
  • MFDSHammer, surgical, manually-operated2025-08-28
    Product approval · Class 1제신 25-1133 호
  • MFDSDilator, general-purpose2025-08-28
    Product approval · Class 1제신 25-1131 호
  • MFDSTissue supplement, collagen2025-08-28
    Product approval · Class 4제허 25-591 호
  • MFDSInstruments, bone, surgical, manually-operated2025-08-28
    Product approval · Class 1제신 25-1130 호
  • MFDSSurgical drill handpiece, manual2025-08-27
    Product approval · Class 1제신 25-1129 호
  • MFDSCurette, manually-operated, reusable2025-08-27
    Product approval · Class 1제신 25-1125 호
  • MFDSForceps, reusable2025-08-27
    Product approval · Class 1제신 25-1122 호
  • MFDSSizer for medical or dental use2025-08-27
    Product approval · Class 1제신 25-1121 호
  • MFDSElevator, surgical, manually-operated2025-08-27
    Product approval · Class 1제신 25-1115 호
  • MFDSLight system, surgical, fibreoptic2025-08-27
    Product approval · Class 1제신 25-1114 호
  • MFDSImplantation assistant, inserter2025-08-01
    Product approval · Class 1제신 25-993 호
  • MFDSChisel, surgical, manually-operated2025-07-31
    Product approval · Class 1제신 25-975 호
  • MFDSClamp, manually-operated, reusable2025-07-24
    Product approval · Class 1제신 25-947 호
  • FDASIGNEX2025-05-29
    510(k) · TraditionalOrthopedicK243469
  • MFDSOrthopaedic bone screw, non-biodegradable2025-04-02
    Product approval · Class 3제허 25-223 호
  • MFDSOrthopaedic bone screw, non-biodegradable2025-03-20
    Product approval · Class 3제허 25-169 호
  • MFDSInstruments, bone, surgical, manually-operated2025-02-21
    Product approval · Class 1제신 25-189 호
  • MFDSSaw, surgical, manually-operated, flexible2025-01-13
    Product approval · Class 1수신 25-75 호
  • FDAFix2Lock (PEEK Self Punching)2024-12-03
    510(k) · SpecialOrthopedicK243470
  • FDAFix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2024-12-03
    510(k) · SpecialOrthopedicK243467
  • MFDSOrthopaedic cement dispenser2024-10-22
    Product approval · Class 1수신 24-1975 호
  • FDASIGNEX2024-06-11
    510(k) · TraditionalOrthopedicK230546
  • MFDSPolydioxanone suture2024-05-28
    Product approval · Class 4제허 24-360 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2024-05-20
    Product approval · Class 2제인 24-496 호
  • MFDSimplant, fixation screwRevoked2024-02-28
    Product approval · Class 3제허 24-151 호
  • FDASuture Wing2023-12-26
    510(k) · SpecialOrthopedicK233659
  • MFDSInstruments, bone, surgical, manually-operated2023-12-19
    Product approval · Class 1제신 23-1784 호
  • MFDSElectrosurgical system, general-purpose2023-11-17
    Product approval · Class 3제허 23-1065 호
  • MFDSGuide for medical use2023-11-01
    Product approval · Class 1제신 23-1583 호
  • MFDSSpinal cage2023-10-24
    Product approval · Class 3제허 23-1003 호
  • MFDSSpinal cage2023-10-24
    Product approval · Class 3제허 23-1002 호
  • MFDSSurgical suture, non-absorbable, with/without needle2023-08-29
    Product approval · Class 3제허 23-876 호
  • MFDSCranioplasty plate2023-08-25
    Product approval · Class 3제허 23-863 호
  • MFDSSpinal cage2023-07-04
    Product approval · Class 3제허 23-746 호
  • FDAFix2Lock(PEEK Self Punching)2023-06-07
    510(k) · SpecialOrthopedicK231322
  • FDAFix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)2023-05-31
    510(k) · SpecialOrthopedicK231326
  • MFDSSurgical drill handpiece, manual2023-05-10
    Product approval · Class 1제신 23-789 호
  • MFDSSpinal cage2023-05-03
    Product approval · Class 3제허 23-556 호
  • MFDSHammer, surgical, manually-operated2023-04-05
    Product approval · Class 1제신 23-618 호
  • MFDSElevator, surgical, manually-operated2023-03-22
    Product approval · Class 1제신 23-574 호
  • MFDSRetractor, surgical, manually-operated2023-03-20
    Product approval · Class 1제신 23-557 호
  • MFDSappliance, orthodontic, anchor2023-03-15
    Product approval · Class 3제허 23-401 호
  • MFDSappliance, orthodontic, anchor2023-03-15
    Product approval · Class 3제허 23-382 호
  • MFDSSpinal internal fixation system, intervertebral body2023-03-08
    Product approval · Class 3제허 23-263 호
  • MFDSSpinal internal fixation system, intervertebral body2023-03-06
    Product approval · Class 3제허 23-219 호
  • MFDSSurgical drill handpiece, manual2023-02-23
    Product approval · Class 1제신 23-217 호
  • MFDSSurgical drill handpiece, manual2023-02-16
    Product approval · Class 1제신 23-192 호
  • MFDSSurgical drill handpiece, manual2023-02-01
    Product approval · Class 1제신 23-124 호
  • MFDSFixative system for laminoplasty and laminectomy2023-01-04
    Product approval · Class 3제허 23-6 호
  • MFDSSurgical suture, non-absorbable, with/without needle2022-12-20
    Product approval · Class 3제허 22-879 호

Showing the 80 most recent of 209 records.

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 52 more patents

AI reads

MAA server logs · IP-verified
116
Times AI engines pulled OSTEONIC Co., Ltd.'s records

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Last 7 days
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Last 30 days
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 10, 2026

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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.32 shared

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

Corentec Co., Ltd.26 shared

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

MEDYSSEY CO.,LTD25 shared

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

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.

JMT CO.,Ltd.21 shared

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

SHINHUNG CO.,LTD19 shared

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

L&K BIOMED CO., LTD.18 shared

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

WSI Co., Ltd.13 shared

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

Organ Eco Tech Co.,Ltd.13 shared

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

DENTIS CO.,LTD12 shared

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

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.9 shared

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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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