Data / Medical devices / Thoracolumbosacral Pedicle Screw System / Taiwan
FDA-registered makers of Thoracolumbosacral Pedicle Screw System in Taiwan: 6 establishments
6 establishments in Taiwan are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 4 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
- Thoracolumbosacral Pedicle Screw System
- Product code
- NKB
- Country
- Taiwan
Makers of Thoracolumbosacral Pedicle Screw System in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Baui Biotech Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 4 | October 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Paonan Biotech Co., Ltd | Taipei, Taiwan | Manufacturer | 2 | July 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | Manufacturer | 1 | March 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Wiltrom Corporation Limited | Zhubei City Hsinchu(County), Taiwan | Complaint file establishment, Manufacturer | 1 | October 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Intai Technology Corp. Implants Business Unit | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microware Precision Co., Ltd. | Taichung, Taiwan | 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.