Solco Biomedical Co., Ltd. · Class II · Cleared Sep 18, 2019
| K-number | K190563 |
| Device name | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage |
| Applicant | Solco Biomedical Co., Ltd. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Sep 18, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov