| K-number | K082838 |
| Device name | ORLUS MINI SCREW |
| Applicant | Ortholution Co., Ltd. |
| Product code | DZE |
| Device class | Class II |
| Decision date | Nov 25, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
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