The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Solar Spine System And 4cis Apollon Spine System.
| Device ID | K102458 |
| 510k Number | K102458 |
| Device Name: | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOLCO BIOMEDICAL CO., LTD. 9700 GREAT SENECA HWY SUITE 302 Rockville, MD 20850 |
| Contact | Saeyoung Ahn |
| Correspondent | Saeyoung Ahn SOLCO BIOMEDICAL CO., LTD. 9700 GREAT SENECA HWY SUITE 302 Rockville, MD 20850 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-06-13 |
| Summary: | summary |