Data / Medical devices / Orthosis, Spinal Pedicle Fixation / South Korea
FDA-registered makers of Orthosis, Spinal Pedicle Fixation in South Korea: 10 establishments
10 establishments in South Korea are registered with the FDA to make Orthosis, Spinal Pedicle Fixation (product code MNI). 7 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
- Orthosis, Spinal Pedicle Fixation
- Product code
- MNI
- Country
- South Korea
Makers of Orthosis, Spinal Pedicle Fixation in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | Manufacturer | 4 | June 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Alpha AI Co., Ltd. | PYEONGTAEK Gyeonggi, South Korea | Manufacturer | 2 | August 15, 2012 | 0 | 0 | 0 | api.fda.gov |
| Corentec Co., Ltd. | Cheonan Si, Chungnam, South Korea | Exporter to the US, Manufacturer | 2 | September 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| L&K Biomed Co.,ltd. | Yongin-SI Gyeonggi, South Korea | Manufacturer | 2 | May 23, 2012 | 0 | 0 | 0 | api.fda.gov |
| BK Meditech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | November 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | October 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Taeyeon Medical Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | April 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Organ Eco Tech | Seongnam-Si Gyeonggi, 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.