The following data is part of a premarket notification filed by Osartis Gmbh with the FDA for Bonos Hv Genta, Bonos Mv Genta, Bonos Lv Genta.
| Device ID | K210125 |
| 510k Number | K210125 |
| Device Name: | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta |
| Classification | Bone Cement |
| Applicant | OSARTIS GmbH Auf Der Beune 101 Munster, DE 64839 |
| Contact | Volker Stirnal |
| Correspondent | Volker Stirnal OSARTIS GmbH Auf Der Beune 101 Munster, DE 64839 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-01-19 |
| Decision Date | 2021-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260056882623 | K210125 | 000 |