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Medical DevicesKOSDAQ 043100559 approvals

Alpha AI Co.,Ltd.

Official website

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

As of 2026-10-10, Alpha AI Co.,Ltd. has 559 Korean MFDS device approvals 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

Founded in 1995 and listed on KOSDAQ in 2000, Alpha AI manufactures biocompatible metal implants and surgical instruments. It supplies biocompatible metal implants including the Spinal system, Trauma system, and Knee Joint, along with about 2,000 types of surgical instruments for surgery, internal medicine, orthopedics, and otolaryngology. Its major product lines hold FDA certification and are exported to the US, Japan, Europe, the Middle East, and South America, while its Healthcare segment (heating mats and other health devices) ceased operations in September 2025.

Regulatory approvals

data.go.kr

559 Korean MFDS device approvals · 1978–2025

  • MFDSResuscitator, pulmonary manually-operated, reusable2025-01-08
    Product approval · Class 2제인 25-4018 호
  • MFDSSpinal cage2024-02-02
    Product approval · Class 3제허 24-86 호
  • MFDSInstruments, bone, surgical, manually-operated2024-01-18
    Product approval · Class 1수신 24-92 호
  • MFDSSurgical drill handpiece, manual2024-01-17
    Product approval · Class 1수신 24-81 호
  • MFDSSurgical drill handpiece, manual2023-12-19
    Product approval · Class 1수신 23-2913 호
  • MFDSeye specula2023-12-18
    Product approval · Class 1제신 23-1778 호
  • MFDSSurgical drill handpiece, manual2023-12-13
    Product approval · Class 1제신 23-1766 호
  • MFDSLacrimal duct dilator2023-12-12
    Product approval · Class 1제신 23-1755 호
  • MFDSSpinal cage2023-01-27
    Product approval · Class 3제허 23-62 호
  • MFDSAlkali water producing equipmentRevoked2022-11-11
    Product approval · Class 2제인 22-4868 호
  • MFDSChisel, surgical, manually-operated2022-08-11
    Product approval · Class 1수신 22-1388 호
  • MFDSEndotherapy forceps, reusable2022-08-02
    Product approval · Class 1제신 22-1084 호
Show 68 more
  • MFDSRetractor, surgical, manually-operated2022-08-02
    Product approval · Class 1제신 22-1083 호
  • MFDSRetractor, surgical, manually-operated2022-08-02
    Product approval · Class 1제신 22-1081 호
  • MFDSEndotherapy dilator, reusable2022-07-29
    Product approval · Class 1제신 22-1069 호
  • MFDSForceps, bone2022-07-27
    Product approval · Class 1제신 22-1057 호
  • MFDSEndoscopic trocar, reusable2022-07-27
    Product approval · Class 1제신 22-1053 호
  • MFDSDilator, general-purpose2022-07-27
    Product approval · Class 1제신 22-1050 호
  • MFDSChisel, surgical, manually-operated2022-07-26
    Product approval · Class 1제신 22-1049 호
  • MFDSHammer, surgical, manually-operated2022-07-26
    Product approval · Class 1제신 22-1048 호
  • MFDSRetractor, surgical, manually-operated2022-07-25
    Product approval · Class 1제신 22-1044 호
  • MFDSElevator, surgical, manually-operated2022-07-25
    Product approval · Class 1제신 22-1043 호
  • MFDSKnife, manually-operated, reusable2022-07-25
    Product approval · Class 1제신 22-1037 호
  • MFDSForceps, bone2022-07-22
    Product approval · Class 1제신 22-1030 호
  • MFDSCurette, manually-operated, reusable2022-07-22
    Product approval · Class 1제신 22-1027 호
  • MFDSSizer for medical or dental use2022-07-19
    Product approval · Class 1수신 22-1249 호
  • MFDSSurgical drill handpiece, manual2022-07-12
    Product approval · Class 1수신 22-1200 호
  • MFDSInstruments, bone, surgical, manually-operated2022-05-11
    Product approval · Class 1수신 22-834 호
  • MFDSTraction unit, air-powered, manually-operated2022-01-14
    Product approval · Class 1제신 22-72 호
  • MFDSInstruments, bone, surgical, manually-operated2021-12-07
    Product approval · Class 1제신 21-1611 호
  • MFDSCurette, manually-operated, reusable2021-12-07
    Product approval · Class 1제신 21-1609 호
  • MFDSSizer for medical or dental use2021-12-07
    Product approval · Class 1제신 21-1608 호
  • MFDSmanually-operated rehabilitation exerciserRevoked2021-06-29
    Product approval · Class 1제신 21-927 호
  • MFDSSpinal internal fixation system, intervertebral body2021-04-12
    Product approval · Class 3제허 21-281 호
  • MFDSSurgical drill handpiece, manual2021-03-18
    Product approval · Class 1수신 21-444 호
  • MFDSInstruments, bone, surgical, manually-operated2021-03-03
    Product approval · Class 1제신 21-282 호
  • MFDSInstruments, bone, surgical, manually-operatedRevoked2021-03-03
    Product approval · Class 1제신 21-281 호
  • MFDSInstruments, bone, surgical, manually-operatedRevoked2021-03-03
    Product approval · Class 1제신 21-279 호
  • MFDSRetractor, surgical, manually-operated2021-03-03
    Product approval · Class 1제신 21-278 호
  • MFDSRasp, surgical, bone, manually-operated2021-03-03
    Product approval · Class 1제신 21-276 호
  • MFDSPuncture instrument, surgical, manually-operated, reusable2021-03-03
    Product approval · Class 1제신 21-275 호
  • MFDSSizer for medical or dental use2021-03-03
    Product approval · Class 1제신 21-274 호
  • MFDSCurette, manually-operated, reusable2021-02-25
    Product approval · Class 1제신 21-249 호
  • MFDSElevator, surgical, manually-operatedRevoked2021-02-24
    Product approval · Class 1제신 21-239 호
  • MFDSHammer, surgical, manually-operated2021-02-22
    Product approval · Class 1제신 21-229 호
  • MFDSPuncture instrument, surgical, manually-operated, reusable2020-08-13
    Product approval · Class 1제신 20-1218 호
  • MFDSSpinal internal fixation system, intervertebral body2020-07-22
    Product approval · Class 3제허 20-596 호
  • MFDSInstruments, bone, surgical, manually-operated2020-07-21
    Product approval · Class 1제신 20-1105 호
  • MFDSSurgical drill handpiece, manual2020-07-17
    Product approval · Class 1제신 20-1089 호
  • MFDSGuide for medical use2020-07-15
    Product approval · Class 1제신 20-1082 호
  • MFDSTool for specimensRevoked2020-07-09
    Product approval · Class 1제신 20-1053 호
  • MFDSTool for specimensRevoked2020-06-29
    Product approval · Class 1제신 20-992 호
  • MFDSDilator, general-purpose2020-06-17
    Product approval · Class 1제신 20-885 호
  • MFDSRetractor, surgical, manually-operated, single-use2020-06-11
    Product approval · Class 2제인 20-4501 호
  • MFDSForceps, dressing, manually-operated, reusable2020-02-05
    Product approval · Class 1제신 20-152 호
  • MFDSElevator, surgical, manually-operated2019-12-31
    Product approval · Class 1제신 19-1762 호
  • MFDSSpinal internal fixation system, intervertebral body2019-11-25
    Product approval · Class 3제허 19-750 호
  • MFDSInstruments, bone, surgical, manually-operatedRevoked2019-11-22
    Product approval · Class 1수신 19-2995 호
  • MFDSDilator, general-purpose2019-11-06
    Product approval · Class 1제신 19-1444 호
  • MFDSAbrasive device2019-11-05
    Product approval · Class 1제신 19-1434 호
  • MFDSInstruments, bone, surgical, manually-operated2019-10-28
    Product approval · Class 1제신 19-1395 호
  • MFDSMeasuring instrument, general-purpose2019-10-15
    Product approval · Class 1제신 19-1343 호
  • MFDSOrthopaedic external fixation system, reprocessed component2019-09-09
    Product approval · Class 1제신 19-1198 호
  • MFDSMattress, pressure dispersion therapyRevoked2019-07-30
    Product approval · Class 2제인 19-4632 호
  • MFDSGlove, patient examinationRevoked2019-03-15
    Product approval · Class 1수신 19-602 호
  • MFDSGuard for medical use2019-02-21
    Product approval · Class 1제신 19-236 호
  • MFDSSpinal cage2018-12-26
    Product approval · Class 3제허 18-824 호
  • MFDSSpinal cage2018-12-19
    Product approval · Class 3제허 18-812 호
  • MFDSRetractor, surgical, manually-operated2018-11-22
    Product approval · Class 1제신 18-1556 호
  • MFDSGuide for medical use2018-11-21
    Product approval · Class 1제신 18-1552 호
  • MFDSSizer for medical or dental use2018-11-19
    Product approval · Class 1제신 18-1538 호
  • MFDSRasp, surgical, bone, manually-operated2018-11-19
    Product approval · Class 1제신 18-1537 호
  • MFDSSurgical drill handpiece, manual2018-10-01
    Product approval · Class 1제신 18-1299 호
  • MFDSSample processing instrumentsRevoked2018-09-21
    Product approval · Class 1체외 제신 18-1288 호
  • MFDSBlood sample preparation instruments, generalRevoked2018-09-20
    Product approval · Class 1체외 제신 18-1267 호
  • MFDSScissors, ophthalmic, reusable2018-07-23
    Product approval · Class 1제신 18-930 호
  • MFDSSurgical staple remover, reusable2018-05-28
    Product approval · Class 1제신 18-656 호
  • MFDSmanually-operated rehabilitation exerciser2018-04-16
    Product approval · Class 1제신 18-460 호
  • MFDSOrthopaedic bone screw, non-biodegradable2018-04-12
    Product approval · Class 3제허 18-255 호
  • MFDSBrush, cleaning2018-03-08
    Product approval · Class 1제신 18-271 호

Showing the 80 most recent of 559 records.

Key disclosures

KRX KIND via OpenDART
Show 23 more events

Patents

KIPRIS · applicant-matched
Show 254 more patents

AI reads

MAA server logs · IP-verified
155
Times AI engines pulled Alpha AI Co.,Ltd.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

2
Fetched fresh mid-answer

Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

153
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

9
live 1
Last 7 days
131
live 2
Last 30 days
155
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot126
  • GoogleGoogleOther16
  • PerplexityPerplexityBot8
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.

SHINHUNG CO.,LTD62 shared

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

DONG-A ST CO.,LTD46 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

MEDYSSEY CO.,LTD42 shared

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

Corentec Co., Ltd.39 shared

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

CG MedTech Co.,Ltd.37 shared

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

OSTEONIC Co., Ltd.32 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.30 shared

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

L&K BIOMED CO., LTD.30 shared

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

WSI Co., Ltd.23 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.21 shared

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

DENTIS CO.,LTD19 shared

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

SEJONG MEDICAL Co.Ltd.,17 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

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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