Intrafuse, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Intrafuse, LLC makes
Intrafuse, LLC manufactures orthopedic fixation systems, including the Flex-Thread Clavicle Pin System and Flex-Thread Fibula Pin System, designed for internal fixation of long bones and clavicles.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Flex-Thread Clavicle Pin System Ref K163488
Regimes: 510(k) Registry: 510(k)Flex-Thread Fibula Pin System Ref K172943
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intrafuse, LLC have in the registry?
The registry currently lists 2 devices for Intrafuse, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intrafuse, LLC's devices?
Among its 2 most recently registered devices, Intrafuse, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Intrafuse, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Intrafuse, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intrafuse, LLC in the registry?
The most recently registered devices listed for Intrafuse, LLC include Flex-Thread Clavicle Pin System and Flex-Thread Fibula Pin System.