OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
FDA 510(k) K211869 · Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
510(k) numberK211869
Submission
- Device name
- OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
- Applicant
- Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Ankara, TR - Received
- June 16, 2021
- Decision date
- May 19, 2022
- 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 |
| 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 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional | Osartis GmbH | 05/18/2021SE |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV GentaLOD · Traditional | Osartis GmbH | 03/19/2021SE |
Questions and answers
When was OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement cleared by the FDA?
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 337 days after the submission was received.
What is the product code of K211869?
The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.