510(k) K211869

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE — Product Code LOD

K211869 is an FDA 510(k) premarket notification submitted by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE for the device "OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027.