LOD
- Product code
- LOD
- Device name
- Bone Cement
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3027
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 72
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254107 | 2026-04-15 | Biomet France | Refobacin Bone Cement R (110034355) | |
| K250760 | 2025-04-02 | Osteoremedies, LLC | SPECTRUM GV Bone Cement | |
| K241674 | 2024-12-05 | Heraeus Medical GmbH | OSTEOPAL® V | FDA |
| K231556 | 2023-12-20 | Osteoremedies, LLC | SPECTRUM® GV Bone Cement |
Official FDA classification page: LOD
Classification and pathway per current FDA publications. Data from openFDA (CC0).