Data / Medical devices / Thoracolumbosacral Pedicle Screw System / China
FDA-registered makers of Thoracolumbosacral Pedicle Screw System in China: 13 establishments
13 establishments in China are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 9 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
- Thoracolumbosacral Pedicle Screw System
- Product code
- NKB
- Country
- China
Makers of Thoracolumbosacral Pedicle Screw System in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 10 | January 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 4 | April 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Sanyou Medical Co. Ltd | Shanghai, China | Manufacturer | 4 | October 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Reach Medical Instrument Co., Ltd | Shanghai, China | Manufacturer | 2 | August 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Geasure Medical Apparatus And Instruments Co., Ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | October 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Double Medical Technology Inc. | Xiamen Fujian, China | Manufacturer | 1 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shandong Kangsheng Medical Devices Co., Ltd. | Taian Shandong, China | Manufacturer | 1 | June 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 1 | August 4, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Decans Medical Devices Co.,ltd. | Jiaxing Zhejiang, China | Manufacturer | 1 | April 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| APS Materials Suzhou | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Dante Co, Ltd | Zibo City Shandong, China | Contract 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.