Data / Medical devices / China / Shandong Kangsheng Medical Devices Co., Ltd.
Shandong Kangsheng Medical Devices Co., Ltd.: FDA-registered device maker in Taian Shandong, China, 1 510(k) clearance
Shandong Kangsheng Medical Devices Co., Ltd. is registered with the FDA (registration 3018780416) in Taian Shandong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018780416
- Address
- No. 9 Nanliu Street, Dawenkou Industrial Park, Daiyue District, tai`an, P.R. China, Taian Shandong, China, 271000
- Owner or operator
- Shandong Kangsheng Medical Devices Co., Ltd. (10081090)
- Roles
- Manufacturer
- First device listed
- March 17, 2021
- Registered through
- 2026
- Brand names listed
- Spinal Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2020 | K190408 | Spinal Fixation System | NKB | Substantially Equivalent | Shangdong Kangsheng Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 16, 2020. 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.