Biomet France
FranceFDA applicant, unverified FDA FEI 3006946279
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Biomet France makes
Biomet France manufactures Refobacin Bone Cement R, an antibiotic-impregnated bone cement designed for orthopedic applications to reduce surgical site infections.
The product is classified as Class II under FDA regulations and is listed via a 510(k) clearance. The company is based in the United States.
Catalogue
Refobacin Bone Cement R (110034355) Ref K254107
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3006946279
- Address
- Plateau de Lautagne, Valence Drome
Frequently asked questions
How many devices does Biomet France have in the registry?
The registry currently lists 1 device for Biomet France. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomet France's devices?
Among its 1 most recently registered device, Biomet France has devices listed in FDA 510(k) (1 device).
What risk classes do Biomet France's devices fall under?
Among its 1 most recently registered device, the classes recorded for Biomet France's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomet France in the registry?
The most recently registered devices listed for Biomet France include Refobacin Bone Cement R (110034355).