The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for 4cis Solar And Apollon Spine Systems.
| Device ID | K082453 |
| 510k Number | K082453 |
| Device Name: | 4CIS SOLAR AND APOLLON SPINE SYSTEMS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST. SUITE 510 Rockville, MD 20850 |
| Contact | Saeyoung Ahn |
| Correspondent | Saeyoung Ahn SOLCO BIOMEDICAL CO., LTD. 155 GIBBS ST. SUITE 510 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 | 2008-08-25 |
| Decision Date | 2008-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373550560 | K082453 | 000 |
| 08806373526176 | K082453 | 000 |