Spinewelding AG
SwitzerlandFDA applicant, unverified
- Devices
- 1
What Spinewelding AG makes
Spinewelding AG manufactures the Elaris Pedicle Screw System, a spinal fixation device designed for internal orthopedic stabilization in surgical procedures.
The company’s portfolio is regulated under FDA 510(k) clearance as a Class II medical device and is listed in the US regulatory registry.
Catalogue
Elaris Pedicle Screw System Ref K183091
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spinewelding AG have in the registry?
The registry currently lists 1 device for Spinewelding AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spinewelding AG's devices?
Among its 1 most recently registered device, Spinewelding AG has devices listed in FDA 510(k) (1 device).
What risk classes do Spinewelding AG's devices fall under?
Among its 1 most recently registered device, the classes recorded for Spinewelding AG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spinewelding AG in the registry?
The most recently registered devices listed for Spinewelding AG include Elaris Pedicle Screw System.