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FDA 510(k)

OGM 1 聚甲基丙烯酸甲酯（PMMA）骨水泥，OGM 1A 聚甲基丙烯酸甲酯（PMMA）骨水泥

K 號：K211869 · 2022-05-19

申請人Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
決定日期2022-05-19
產品代碼LOD
諮詢委員會或
決定相當於

器材摘要

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement is the device name listed in this FDA 510(k) record. The listed applicant is Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K211869. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement?

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. The 510(k) number is K211869.

When did OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement receive FDA 510(k) clearance?

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement received FDA 510(k) clearance on 2022-05-19, under 510(k) number K211869.

Who is the listed applicant for OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement?

The FDA 510(k) record lists Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement?

The FDA product code for OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement is LOD.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LOD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254107Refobacin骨水泥R (110034355)Biomet FranceK250760SPECTRUM GV 骨水泥Osteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV 骨水泥Osteoremedies, LLCK211163骨水泥Genta，骨水泥HV，骨水泥LVTecres S.P.A.K212729骨水泥-正常濃度Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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