The following data is part of a premarket notification filed by Shangdong Kangsheng Medical Devices Co., Ltd. with the FDA for Spinal Fixation System.
| Device ID | K190408 |
| 510k Number | K190408 |
| Device Name: | Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Shangdong Kangsheng Medical Devices Co., Ltd. North Of Industrial Park, Dawenkou Gypsum Tai'an City, CN 271000 |
| Contact | Wenxing Dong |
| Correspondent | Jonathan Hu Medwheat (Shanghai) Medical Technology Co. Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai, CN 200082 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2020-06-16 |