The following data is part of a premarket notification filed by Beijing Keyi Medical Device Technology Co., Ltd. with the FDA for Locking Plate System.
| Device ID | K162380 |
| 510k Number | K162380 |
| Device Name: | Locking Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. BUILDING 1, NO. 11, 3RD JINGHAI STREET Beijing, CN 100176 |
| Contact | Cindy Nie |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2017-05-02 |
| Summary: | summary |