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FDA 510(k)

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

Número K: K211869 · 2022-05-19

RequerenteOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Data da decisão2022-05-19
Código do produtoLOD
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: LOD)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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