Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Lumbar / China
FDA-registered makers of Intervertebral Fusion Device With Bone Graft, Lumbar in China: 14 establishments
14 establishments in China are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX). 8 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
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Product code
- MAX
- Country
- China
Makers of Intervertebral Fusion Device With Bone Graft, Lumbar 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 | 11 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Yonghua Medical Instruments Co.,ltd | Changzhou Jiangsu, China | Manufacturer | 2 | October 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Sanyou Medical Co. Ltd | Shanghai, China | Manufacturer | 2 | December 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Geasure Medical Apparatus And Instruments Co., Ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Double Medical Technology Inc. | Xiamen Fujian, China | Manufacturer | 1 | February 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 1 | July 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Reach Medical Instrument Co., Ltd | Shanghai, China | Manufacturer | 1 | November 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Decans Medical Devices Co.,ltd. | Jiaxing Zhejiang, China | Manufacturer | 1 | October 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang City Jiangsu, 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 | |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhisu Health Tech Jiaxing Co. Ltd | Tongxiang City Zhejiang, 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 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.