The following data is part of a premarket notification filed by Canwell Medical Co., Ltd. with the FDA for Spinal Fixation System.
| Device ID | K161151 |
| 510k Number | K161151 |
| Device Name: | Spinal Fixation System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CANWELL MEDICAL CO., LTD. NO. 466 SOUTH XIANHUA STREET,HIGH-TECH INDUSTRAIL ZONE Jinhua, CN 321016 |
| Contact | Chen Hui |
| Correspondent | Mike Gu OSMUNDA MEDICAL DEVICE SERVICE GROUP LEVEL 7, JIN GUI BUSINESS CENTER, 982 CONGYUN ROAD BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-09-21 |
| Summary: | summary |