Extraortho, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Extraortho, Inc. makes
Extraortho, Inc. manufactures the XTRAFIX External Fixation System, a device used for stabilizing and supporting bone fractures or deformities through external skeletal fixation.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Xtrafix External Fixation System Ref K111155
510(k) 510(k)Xtrafix External Fixation System Ref K113383
510(k) 510(k)
Frequently asked questions
How many devices does Extraortho, Inc. have in the registry?
The registry currently lists 2 devices for Extraortho, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Extraortho, Inc.'s devices?
Among its 2 most recently registered devices, Extraortho, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Extraortho, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Extraortho, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Extraortho, Inc. in the registry?
The most recently registered devices listed for Extraortho, Inc. include XTRAFIX EXTERNAL FIXATION SYSTEM.