Biotekne SRL
ItalyFDA applicant, unverified
- Devices
- 1
What Biotekne SRL makes
Biotekne Srl manufactures the meso-relle series, a set of Class II medical devices designed for orthopedic applications, including spinal and trauma fixation systems. These products include models such as the AAL34, AAL36, and AM30G, which are intended for internal skeletal fixation and stabilization.
The portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the U.S. regulatory registry. The company is based in the United States.
Catalogue
meso-relle (AAL34, AAL36, AM30G) Ref K161255
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotekne Srl have in the registry?
The registry currently lists 1 device for Biotekne Srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotekne Srl's devices?
Among its 1 most recently registered device, Biotekne Srl has devices listed in FDA 510(k) (1 device).
What risk classes do Biotekne Srl's devices fall under?
Among its 1 most recently registered device, the classes recorded for Biotekne Srl's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotekne Srl in the registry?
The most recently registered devices listed for Biotekne Srl include meso-relle (AAL34, AAL36, AM30G).