The following data is part of a premarket notification filed by Aap Biomaterials Gmbh & Co. Kg with the FDA for Bonos R Genta 1x20 Model 01-0228; Bonos R Genta 2x20 Model 01-0229; Bonos R Genta 1x40 Model 01-0217; Bonos R Genta 2x40.
| Device ID | K123081 |
| 510k Number | K123081 |
| Device Name: | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 |
| 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 | Yes |
| Date Received | 2012-10-01 |
| Decision Date | 2013-03-07 |
| Summary: | summary |