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FDA 510(k)

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

K-Number: K211869 · 2022-05-19

ApplicantOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Decision Date2022-05-19
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. The 510(k) number is K211869.

When was OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement approved by the FDA?

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

What company makes 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 manufactured by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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