Sodem Diffusion SA
Country not established
- Devices
- 3
What Sodem Diffusion SA makes
Sodem Diffusion SA manufactures high-speed surgical systems designed for neurosurgery and median sternotomy procedures. These devices are engineered to provide precise cutting and bone preparation in sterile environments, supporting minimally invasive and open surgical techniques. The systems are tailored for use in cranial, spinal, and thoracic surgeries, where controlled bone manipulation is critical.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with submissions documented via the 510(k) pathway. These products are intended for use in the United States, adhering to regulatory requirements for surgical instruments and bone-cutting systems. The manufacturer operates from the US, aligning its offerings with domestic medical device compliance standards.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Sodem High Speed System Ref K954080
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sodem Diffusion SA have in the registry?
The registry currently lists 3 devices for Sodem Diffusion SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sodem Diffusion SA's devices?
Among its 3 most recently registered devices, Sodem Diffusion SA has devices listed in FDA 510(k) (3 devices).
What risk classes do Sodem Diffusion SA's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sodem Diffusion SA's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sodem Diffusion SA in the registry?
The most recently registered devices listed for Sodem Diffusion SA include SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY, SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY and SODEM HIGH SPEED SYSTEM.