Fixano SA
Country not established
- Devices
- 5
What Fixano SA makes
Fixano SA manufactures orthopedic fixation devices, including intramedullary rods (RADIOFIX), nail systems (FLEX-NAILS), interlocking screws (TWIN FIX), micro-screws (MICROFIX), and proximal femoral nails (PF2). These products are designed for internal fixation in long bone fractures and hip surgeries.
The company’s portfolio is classified under FDA’s Class II medical devices and is listed in the 510(k) premarket notification registry. These devices are regulated under the US Food and Drug Administration’s framework for orthopedic fixation systems.
Catalogue
Radiofix Ref K012078
Regimes: 510(k) Registry: 510(k)Flex-Nails Ref K012161
Regimes: 510(k) Registry: 510(k)Twin Fix Ref K022771
Regimes: 510(k) Registry: 510(k)Microfix Ref K023314
Regimes: 510(k) Registry: 510(k)PF2 Ref K012062
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fixano SA have in the registry?
The registry currently lists 5 devices for Fixano SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fixano SA's devices?
Among its 5 most recently registered devices, Fixano SA has devices listed in FDA 510(k) (5 devices).
What risk classes do Fixano SA's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Fixano SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fixano SA in the registry?
The most recently registered devices listed for Fixano SA include RADIOFIX, FLEX-NAILS, TWIN FIX and MICROFIX.