BonOs Inject, Pedicle screw kits, Cement pusher
FDA 510(k) K202458 · Osartis GmbH
510(k) numberK202458
Submission
- Device name
- BonOs Inject, Pedicle screw kits, Cement pusher
- Applicant
- Osartis GmbH
Münster, DE - Received
- August 27, 2020
- Decision date
- May 18, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOD – Bone Cement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254107 | Refobacin Bone Cement R (110034355)LOD · Traditional | Biomet France | 04/15/2026SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | Osteoremedies, LLC | 04/02/2025SE |
| K241674 | Osteopal® VLOD · Traditional | Heraeus Medical GmbH | 12/05/2024SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | Osteoremedies, LLC | 12/20/2023SE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional | Tecres S.P.A. | 01/09/2023SE |
| K212729 | Bone Cement-Normal ViscosityLOD · Traditional | Biomecanica Industria E Comerciode Produtos… | 05/31/2022SE |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…LOD · Traditional | Ormed Grup Medikal Turizm Saglik Hizmetleri… | 05/19/2022SE |
| K213812 | PALACOS MV proLOD · Traditional | Heraeus Medical GmbH | 02/02/2022SE |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional | Heraeus Medical GmbH | 07/09/2021SE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | Osartis GmbH | 03/19/2021SE |
More from Osartis GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsMBB · Traditional | 11/20/2024SE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | 03/19/2021SE |
| K210120 | BonOs HV, BonOs MV, BonOs LVLOD · Traditional | 03/19/2021SE |
| K192394 | Hi-Fatigue Bone CementLOD · Traditional | 12/02/2019SE |
| K192379 | Hi-Fatigue G Bone CementLOD · Traditional | 11/27/2019SE |
Questions and answers
When was BonOs Inject, Pedicle screw kits, Cement pusher cleared by the FDA?
BonOs Inject, Pedicle screw kits, Cement pusher (K202458) received a 510(k) decision of Substantially Equivalent on May 18, 2021, 264 days after the submission was received.
What is the product code of K202458?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.