| K-number | K040004 |
| Device name | ORTHOCORD SUTURE |
| Applicant | Depuy Mitek |
| Product code | NEW |
| Device class | Class II |
| Decision date | Apr 13, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 878.4840 |
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