The following data is part of a premarket notification filed by Curasan Ag with the FDA for Modification To Cerasorb Ortho.
| Device ID | K031651 |
| 510k Number | K031651 |
| Device Name: | MODIFICATION TO CERASORB ORTHO |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CURASAN AG LINDIGSTRASSE 4 Kleinostheim, DE 63801 |
| Contact | Rolf Kaufmann |
| Correspondent | Rolf Kaufmann CURASAN AG LINDIGSTRASSE 4 Kleinostheim, DE 63801 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-08-13 |
| Summary: | summary |