Data / Medical devices / Plate, Fixation, Bone / South Korea
FDA-registered makers of Plate, Fixation, Bone in South Korea: 7 establishments
7 establishments in South Korea are registered with the FDA to make Plate, Fixation, Bone (product code HRS). 7 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
- Plate, Fixation, Bone
- Product code
- HRS
- Country
- South Korea
Makers of Plate, Fixation, Bone in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 24 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 24 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | Manufacturer | 5 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | Manufacturer | 3 | March 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 2 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | Manufacturer | 1 | July 11, 2005 | 0 | 0 | 0 | api.fda.gov |
| Medifield Medical Co., Ltd. | Pocheon Gyeonggi, South Korea | Manufacturer | 1 | June 4, 2025 | 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.