The following data is part of a premarket notification filed by Bonesupport Ab with the FDA for Cerament Ibone Void Filler High Contrast, Model A 0210-12.
| Device ID | K090871 |
| 510k Number | K090871 |
| Device Name: | CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BONESUPPORT AB SCHEELEVAGEN 19A IDEON SCIENCE PARK Lund, SE Se 223-70 |
| Contact | Ann-christine Provoost |
| Correspondent | Ann-christine Provoost BONESUPPORT AB SCHEELEVAGEN 19A IDEON SCIENCE PARK Lund, SE Se 223-70 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-03-30 |
| Decision Date | 2009-09-04 |
| Summary: | summary |