The following data is part of a premarket notification filed by Aap Biomaterials Gmbh with the FDA for Bonos Inject.
| Device ID | K090460 |
| 510k Number | K090460 |
| Device Name: | BONOS INJECT |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | AAP BIOMATERIALS GMBH LAGERSTRASSE 11-15 Dieburg, DE D-64807 |
| Contact | Volker Stirnal |
| Correspondent | Volker Stirnal AAP BIOMATERIALS GMBH LAGERSTRASSE 11-15 Dieburg, DE D-64807 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-04-14 |
| Summary: | summary |