Imds (Innovative MEdical Device Systems) - Leis ME
Country not established
- Devices
- 1
What Imds (Innovative MEdical Device Systems) - Leis ME makes
Imds (Innovative Medical Device Systems) - Leis ME manufactures the AXIA Radial Head System, a surgical implant designed for use in radial head arthroplasty to restore function in the elbow joint following trauma or degenerative conditions.
The AXIA Radial Head System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Axia Radial Head System Ref K132735
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Imds (Innovative MEdical Device Systems) - Leis ME have in the registry?
The registry currently lists 1 device for Imds (Innovative MEdical Device Systems) - Leis ME. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imds (Innovative MEdical Device Systems) - Leis ME's devices?
Among its 1 most recently registered device, Imds (Innovative MEdical Device Systems) - Leis ME has devices listed in FDA 510(k) (1 device).
What risk classes do Imds (Innovative MEdical Device Systems) - Leis ME's devices fall under?
Among its 1 most recently registered device, the classes recorded for Imds (Innovative MEdical Device Systems) - Leis ME's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Imds (Innovative MEdical Device Systems) - Leis ME in the registry?
The most recently registered devices listed for Imds (Innovative MEdical Device Systems) - Leis ME include AXIA RADIAL HEAD SYSTEM.