The following data is part of a premarket notification filed by Bone Support Ab with the FDA for Cerament Bone Void Filler.
| Device ID | K051951 |
| 510k Number | K051951 |
| Device Name: | CERAMENT BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BONE SUPPORT AB 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman BONE SUPPORT AB 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-09-28 |
| Summary: | summary |