Data / Medical devices / Thoracolumbosacral Pedicle Screw System / South Korea
FDA-registered makers of Thoracolumbosacral Pedicle Screw System in South Korea: 15 establishments
15 establishments in South Korea are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 14 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Thoracolumbosacral Pedicle Screw System
- Product code
- NKB
- Country
- South Korea
Makers of Thoracolumbosacral Pedicle Screw System 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 | 17 | May 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | Manufacturer | 8 | August 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Manufacturer | 4 | February 6, 2024 | 0 | 1 | 0 | api.fda.gov |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 4 | October 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | Manufacturer | 3 | November 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 3 | August 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | May 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| JMT Co., Ltd. | Yangju-si Gyeonggi, South Korea | Manufacturer | 2 | June 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Organ Eco Tech | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 2 | December 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 1 | March 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 1 | November 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 1 | November 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | November 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| TDM Co.,ltd | Buk-gu Gwangju, South Korea | Manufacturer | 1 | May 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| HO MEDI Co., Ltd | Yangju Gyeonggi, South Korea | Contract 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.