LOD — Bone Cement Class II
FDA product code LOD covers "Bone Cement", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LOD
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254107 | biomet france | Refobacin Bone Cement R (110034355) | April 15, 2026 |
| K250760 | osteoremedies | SPECTRUM GV Bone Cement | April 2, 2025 |
| K241674 | heraeus medical | OSTEOPAL® V | December 5, 2024 |
| K231556 | osteoremedies | SPECTRUM® GV Bone Cement | December 20, 2023 |
| K211163 | tecres | Bone Cement Genta, Bone Cement HV, Bone Cement LV | January 9, 2023 |
| K212729 | biomecanica industria e comerciode produtos ortopedicos ltda | Bone Cement-Normal Viscosity | May 31, 2022 |
| K211869 | ormed grup medikal turizm saglik hizmetleri sanayi ve | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate ( | May 19, 2022 |
| K213812 | heraeus medical | PALACOS MV pro | February 2, 2022 |
| K210607 | heraeus medical | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | July 9, 2021 |
| K202458 | osartis | BonOs Inject, Pedicle screw kits, Cement pusher | May 18, 2021 |
| K210120 | osartis | BonOs HV, BonOs MV, BonOs LV | March 19, 2021 |
| K210125 | osartis | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | March 19, 2021 |
| K202475 | heraeus medical | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | November 23, 2020 |
| K193061 | g21 | G3 40 Radiopaque Bone Cement | March 19, 2020 |
| K193059 | g21 | G1 40 Radiopaque Bone Cement | March 19, 2020 |
| K192394 | osartis | Hi-Fatigue Bone Cement | December 2, 2019 |
| K192379 | osartis | Hi-Fatigue G Bone Cement | November 27, 2019 |
| K190766 | heraeus medical | PALACOS fast R+G | May 31, 2019 |
| K181282 | g21 | G3A 40 Bone Cement | January 9, 2019 |
| K182260 | heraeus medical | PALACOS MV | September 17, 2018 |