Biospace Med
Country not established
- Devices
- 4
What Biospace Med makes
Biospace Med manufactures surgical navigation systems, including the STEREOS Workstation, which supports real-time imaging and 3D planning for orthopedic and spinal procedures. The company also produces the EOS imaging system, a low-dose X-ray device designed for full-body scans and musculoskeletal assessments.
The company’s portfolio consists of Class II medical devices, all of which are cleared via the FDA’s 510(k) pathway. These devices are listed under the US regulatory framework and are based in the United States.
Catalogue
Stereos Workstation Ref K080529
Regimes: 510(k) Registry: 510(k)Stereos Workstation Ref K090050
Regimes: 510(k) Registry: 510(k)Stereos Workstation Ref K101398
Regimes: 510(k) Registry: 510(k)Eos Ref K071546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biospace Med have in the registry?
The registry currently lists 4 devices for Biospace Med. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biospace Med's devices?
Among its 4 most recently registered devices, Biospace Med has devices listed in FDA 510(k) (4 devices).
What risk classes do Biospace Med's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biospace Med's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biospace Med in the registry?
The most recently registered devices listed for Biospace Med include STEREOS WORKSTATION and EOS.