The following data is part of a premarket notification filed by Artimplant Ab with the FDA for Artelon Spacer Cmc-1.
| Device ID | K040070 |
| 510k Number | K040070 |
| Device Name: | ARTELON SPACER CMC-1 |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Contact | Marie Marlow |
| Correspondent | Marie Marlow ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-14 |
| Decision Date | 2004-09-21 |
| Summary: | summary |