Novatsep
FranceFDA applicant, unverified
- Devices
- 1
What Novatsep makes
Novatsep manufactures compressive osteosynthesis staples, including the ARCAD and EXPRESS models, designed for internal fixation of bone fractures to promote stable healing.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novatsep have in the registry?
The registry currently lists 1 device for Novatsep. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novatsep's devices?
Among its 1 most recently registered device, Novatsep has devices listed in FDA 510(k) (1 device).
What risk classes do Novatsep's devices fall under?
Among its 1 most recently registered device, the classes recorded for Novatsep's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novatsep in the registry?
The most recently registered devices listed for Novatsep include ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE.