The following data is part of a premarket notification filed by Beijing Keyi Medical Device Technology Co., Ltd. with the FDA for Keyi Spinal Fixation System.
| Device ID | K190567 |
| 510k Number | K190567 |
| Device Name: | KeYi Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road Beijing, CN 100176 |
| Contact | Jenny Jiang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-05-08 |