The following data is part of a premarket notification filed by Curasan Ag with the FDA for Cerasorb Ortho.
| Device ID | K014156 |
| 510k Number | K014156 |
| Device Name: | CERASORB ORTHO |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
| Contact | Eric Wiechert |
| Correspondent | Eric Wiechert CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-03-18 |
| Summary: | summary |