Company ยท DE
Osartis GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2024 | K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds Osartis GmbH, DE | MBB |
| May 18, 2021 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher Osartis GmbH, DE | LOD |
| Mar 19, 2021 | K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta Osartis GmbH, DE | LOD |
| Mar 19, 2021 | K210120 | BonOs HV, BonOs MV, BonOs LV Osartis GmbH, DE | LOD |
| Dec 2, 2019 | K192394 | Hi-Fatigue Bone Cement Osartis GmbH, DE | LOD |
| Nov 27, 2019 | K192379 | Hi-Fatigue G Bone Cement Osartis GmbH, DE | LOD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||