Armstrong Healthcare, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 3
What Armstrong Healthcare, Ltd. makes
Armstrong Healthcare, Ltd. manufactures the ENDOASSIST system, a surgical device designed to assist in minimally invasive orthopedic procedures, particularly for hip and knee replacements.
The ENDOASSIST system is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Endoassist Ref K043284
Regimes: 510(k) Registry: 510(k)Pathfinder Ref K041477
Regimes: 510(k) Registry: 510(k)Endoassist Ref K973249
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Armstrong Healthcare, Ltd. have in the registry?
The registry currently lists 3 devices for Armstrong Healthcare, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Armstrong Healthcare, Ltd.'s devices?
Among its 3 most recently registered devices, Armstrong Healthcare, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Armstrong Healthcare, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Armstrong Healthcare, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Armstrong Healthcare, Ltd. in the registry?
The most recently registered devices listed for Armstrong Healthcare, Ltd. include ENDOASSIST and PATHFINDER.