The following data is part of a premarket notification filed by Jiangsu Trauhui Medical Instrument Co.,ltd. with the FDA for Comus Locking Plate Systems.
| Device ID | K190842 |
| 510k Number | K190842 |
| Device Name: | Comus Locking Plate Systems |
| Classification | Plate, Fixation, Bone |
| Applicant | Jiangsu Trauhui Medical Instrument Co.,Ltd. No.2 Longqing Road, Wujin Hi-Tech Industrial Zone Changzhou, CN 213168 |
| Contact | Zhou Yu |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Consulting Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2020-02-03 |