Data / Medical devices / Orthosis, Spinal Pedicle Fixation / China
FDA-registered makers of Orthosis, Spinal Pedicle Fixation in China: 11 establishments
11 establishments in China are registered with the FDA to make Orthosis, Spinal Pedicle Fixation (product code MNI). 3 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
- China
Makers of Orthosis, Spinal Pedicle Fixation in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Changzhou Yonghua Medical Instruments Co.,ltd | Changzhou Jiangsu, China | Manufacturer | 1 | August 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Double Medical Technology Inc. | Xiamen Fujian, China | Manufacturer | 1 | August 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 1 | April 1, 2016 | 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 | |
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Sanyou Medical Co. Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang City Jiangsu, China | 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.