Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Lumbar / South Korea
FDA-registered makers of Intervertebral Fusion Device With Bone Graft, Lumbar in South Korea: 15 establishments
15 establishments in South Korea are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Product code
- MAX
- Country
- South Korea
Makers of Intervertebral Fusion Device With Bone Graft, Lumbar 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 | Manufacturer | 11 | July 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | Manufacturer | 8 | December 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Manufacturer | 4 | October 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 4 | April 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | Manufacturer | 2 | September 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | October 1, 2014 | 0 | 0 | 0 | api.fda.gov |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 2 | March 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 1 | June 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 1 | June 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Organ Eco Tech | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 1 | October 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | Manufacturer | 1 | August 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| CTL Biotec | Daegu, 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 | |
| Institute Of Advanced Convergence Technology (iact) | Daegu, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JMT Co., Ltd. | Yangju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.