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 | K203233 |
| 510k Number | K203233 |
| 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 | Hee-Hoon Kim |
| Correspondent | Soo-Min Hong Solco Biomedical Co., Ltd. 154 Seotan-ro, Seotan-myeon Pyeongtaek, KR 17704 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2022-06-01 |