The following data is part of a premarket notification filed by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve with the FDA for Ogm 1 Polymethylmethacrylate (pmma) Bone Cement, Ogm 1a Polymethylmethacrylate (pmma) Bone Cement.
| Device ID | K211869 |
| 510k Number | K211869 |
| Device Name: | OGM 1 Polymethylmethacrylate (PMMA) Bone Cement, OGM 1A Polymethylmethacrylate (PMMA) Bone Cement |
| Classification | Bone Cement |
| Applicant | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve Ticaret Limited S Macun Mahallesi 177 Cadde No:19 H/7 Timko Is Yerleri Ankara, TR 06200 |
| Contact | Kenan Kara |
| Correspondent | Mehmet Fatih Ormeci Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, TR 06830 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-06-16 |
| Decision Date | 2022-05-19 |