The following data is part of a premarket notification filed by Beijing Keyi Medical Device Technology Co., Ltd. with the FDA for Keyi Total Hip System.
| Device ID | K191826 |
| 510k Number | K191826 |
| Device Name: | KeYi Total Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road Beijing, CN 100176 |
| Contact | Jenny Jiang |
| Correspondent | Jenny Jiang Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road Beijing, CN 100176 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-08 |
| Decision Date | 2020-05-14 |