K211869 is an FDA 510(k) clearance for the OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE (Ankara, TR). The FDA issued a Cleared decision on May 19, 2022, 337 days after receiving the submission on June 16, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K211869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2021 |
| Decision Date | May 19, 2022 |
| Days to Decision | 337 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |