The following data is part of a premarket notification filed by Jiangsu Trauhui Medical Instrument Co.,ltd. with the FDA for Cellent Spinal Systems.
| Device ID | K172826 |
| 510k Number | K172826 |
| Device Name: | Cellent Spinal Systems |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Jiangsu Trauhui Medical Instrument Co.,Ltd. No.2 Longqing Road, Wujin Hi-Tech Industrial Zone Changzhou, CN 213118 |
| Contact | Zhou Yu |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-10-10 |
| Summary: | summary |