The following data is part of a premarket notification filed by Beijing Weigao Yahua Artificial Joint Development Co. Ltd. with the FDA for Yahua Spinal System.
| Device ID | K152324 |
| 510k Number | K152324 |
| Device Name: | YAHUA Spinal System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. NO.7, NIUHUI STREET, NIULANSHAN TOWN, SHUNYI DISTRICT Beijing, CN 101301 |
| Contact | Xinjian Lv |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2016-02-01 |
| Summary: | summary |