Zygomatics, Ltd.
United KingdomFDA 510(k) applicant, unverified
- Devices
- 1
What Zygomatics, Ltd. makes
Zygomatics, Ltd. manufactures the RAPID IMF, a device designed for internal fixation of midface fractures, facilitating surgical stabilization of bone fragments in reconstructive procedures.
The RAPID IMF 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
Rapid Imf Ref K030605
510(k) 510(k)
Frequently asked questions
How many devices does Zygomatics, Ltd. have in the registry?
The registry currently lists 1 device for Zygomatics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zygomatics, Ltd.'s devices?
Among its 1 most recently registered device, Zygomatics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Zygomatics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Zygomatics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zygomatics, Ltd. in the registry?
The most recently registered devices listed for Zygomatics, Ltd. include RAPID IMF.