Data / Medical devices / Appliance, Fixation, Spinal Intervertebral Body / South Korea
FDA-registered makers of Appliance, Fixation, Spinal Intervertebral Body in South Korea: 14 establishments
14 establishments in South Korea are registered with the FDA to make Appliance, Fixation, Spinal Intervertebral Body (product code KWQ). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Appliance, Fixation, Spinal Intervertebral Body
- Product code
- KWQ
- Country
- South Korea
Makers of Appliance, Fixation, Spinal Intervertebral Body in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 7 | May 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Manufacturer | 5 | February 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Organ Eco Tech | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 3 | May 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | Manufacturer | 2 | March 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | Manufacturer | 1 | January 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 1 | January 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | May 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 1 | July 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 1 | July 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | Manufacturer | 1 | April 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HO MEDI Co., Ltd | Yangju Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.