The following data is part of a premarket notification filed by Curasan Ag with the FDA for Ceracell Ortho Foam.
| Device ID | K181721 |
| 510k Number | K181721 |
| Device Name: | Ceracell Ortho Foam |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | curasan AG Lindigstrasse 4 Kleinostheim, DE 63801 |
| Contact | Gregor Thomas |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2018-09-17 |
| Summary: | summary |