The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Vane Spine System.
| Device ID | K121615 |
| 510k Number | K121615 |
| Device Name: | 4CIS VANE SPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SOLCO BIOMEDICAL CO., LTD. 9700 GREAT SENECA HIGHWAY STE 302 Rockville, MD 20850 |
| Contact | Saeyoung Ahn |
| Correspondent | Saeyoung Ahn SOLCO BIOMEDICAL CO., LTD. 9700 GREAT SENECA HIGHWAY STE 302 Rockville, MD 20850 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800033350217 | K121615 | 000 |
| 08800033350200 | K121615 | 000 |
| 08800033350194 | K121615 | 000 |
| 08800033350187 | K121615 | 000 |