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 | K050471 |
| 510k Number | K050471 |
| Device Name: | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE 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 | 2005-02-23 |
| Decision Date | 2005-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373556333 | K050471 | 000 |
| 08806373545092 | K050471 | 000 |
| 08806373525964 | K050471 | 000 |