The following data is part of a premarket notification filed by Osartis Gmbh with the FDA for Hi-fatigue Bone Cement.
| Device ID | K192394 |
| 510k Number | K192394 |
| Device Name: | Hi-Fatigue Bone Cement |
| Classification | Bone Cement |
| Applicant | OSARTIS GmbH Lagerstrasse 11-15 Dieburg, DE 64807 |
| Contact | Volker Stirnal |
| Correspondent | Volker Stirnal OSARTIS GmbH Lagerstrasse 11-15 Dieburg, DE 64807 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2019-12-02 |