Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
TürkiyeFDA applicant, unverified
- Devices
- 1
What Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE makes
Ormed Grup Medikal produces polymethylmethacrylate (PMMA) bone cement formulations, including OGM 1 and OGM 1A, used primarily for orthopedic applications such as spinal and joint surgeries.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement Ref K211869
Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED510(k)
Frequently asked questions
How many devices does Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE have in the registry?
The registry currently lists 1 device for Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE's devices?
Among its 1 most recently registered device, Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE in the registry?
The most recently registered devices listed for Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE include OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement.