Data / Medical devices / Intervertebral Fusion Device With Integrated Fixation, Cervical / South Korea
FDA-registered makers of Intervertebral Fusion Device With Integrated Fixation, Cervical in South Korea: 7 establishments
7 establishments in South Korea are registered with the FDA to make Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE). 6 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
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Product code
- OVE
- Country
- South Korea
Makers of Intervertebral Fusion Device With Integrated Fixation, Cervical in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| CG MedTech Co., Ltd. | Uijeongbu-si Gyeonggi, South Korea | Manufacturer | 3 | April 19, 2024 | 0 | 1 | 0 | api.fda.gov |
| GS Medical Co., Ltd. | Heungdeok-gu, Cheongju-si Chungbuk, South Korea | Manufacturer | 2 | July 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Siheung-si Gyeonggi, South Korea | Manufacturer | 1 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jeil Medical Corporation | Seoul, South Korea | Manufacturer | 1 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medyssey Co., Ltd. | Jecheon-si Chungbuk, South Korea | Manufacturer | 1 | June 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Organ Eco Tech | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 1 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| CTL Biotec | Daegu, 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.