| K-number | K040070 |
| Device name | ARTELON SPACER CMC-1 |
| Applicant | Artimplant AB |
| Product code | KYI |
| Device class | Class II |
| Decision date | Sep 21, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 888.3770 |
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