The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for The 4cis Spinal System And 4cis Low Back System.
| Device ID | K043578 |
| 510k Number | K043578 |
| Device Name: | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817 |
| Contact | Saeyoung Ahn |
| Correspondent | Saeyoung Ahn SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-03-07 |
| Summary: | summary |