Australian Surgical Design & Manufacture
Country not established
- Devices
- 1
What Australian Surgical Design & Manufacture makes
The company designs and manufactures an active unicompartmental knee system, a partial knee replacement intended for targeted joint resurfacing in specific osteoarthritis cases.
This product is classified as Class II under FDA regulations and is listed via 510(k) clearance. The company is based in the United States.
Catalogue
Active Unicompartmental Knee System Ref K060412
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Australian Surgical Design & Manufacture have in the registry?
The registry currently lists 1 device for Australian Surgical Design & Manufacture. Devices recorded under merged duplicate company entries are counted once.
Which registries list Australian Surgical Design & Manufacture's devices?
Among its 1 most recently registered device, Australian Surgical Design & Manufacture has devices listed in FDA 510(k) (1 device).
What risk classes do Australian Surgical Design & Manufacture's devices fall under?
Among its 1 most recently registered device, the classes recorded for Australian Surgical Design & Manufacture's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Australian Surgical Design & Manufacture in the registry?
The most recently registered devices listed for Australian Surgical Design & Manufacture include ACTIVE UNICOMPARTMENTAL KNEE SYSTEM.