The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis® Chiron Spinal Fixation System.
| Device ID | K190471 |
| 510k Number | K190471 |
| Device Name: | 4CIS® Chiron Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Solco Biomedical Co., Ltd. 154 Seotan-Ro, Seotan-Myeon Pyeongtaek, KR 17704 |
| Contact | Kim Il |
| Correspondent | Hwi-geun Yu First Gold Corp. 154, Seotan-ro, Gyeonggi-do Pyeongtaek-si, Gyeonggi-do, KR 17704 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-07-24 |
| Summary: | summary |