The following data is part of a premarket notification filed by Aap Biomaterials Gmbh & Co. Kg with the FDA for Bonos R 1x20, Bonos R 2x20, Bonos R 1x40, Bonos R 2x40, Bonos R 1x60.
| Device ID | K123225 |
| 510k Number | K123225 |
| Device Name: | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 |
| Classification | Bone Cement |
| Applicant | AAP BIOMATERIALS GMBH & CO. KG LAGERSTRASSE 11-15 Dieburg, DE 64807 |
| Contact | Volker Stirnal |
| Correspondent | Volker Stirnal AAP BIOMATERIALS GMBH & CO. KG LAGERSTRASSE 11-15 Dieburg, DE 64807 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-03-15 |
| Summary: | summary |