TMJ Concepts
Country not established
- Devices
- 1
What TMJ Concepts makes
TMJ Concepts designs custom-fitted TMJ (temporomandibular joint) reconstruction prostheses, which are used to replace or repair damaged joint surfaces in patients requiring surgical intervention for TMJ disorders or trauma. These devices are tailored to individual anatomical requirements to restore joint function and stability.
The company’s prostheses fall under FDA Class III regulation, requiring a Premarket Approval (PMA) application for market authorisation. These devices are listed in the FDA’s PMA registry, reflecting their stringent regulatory pathway. TMJ Concepts operates from the United States.
Catalogue
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does TMJ Concepts have in the registry?
The registry currently lists 1 device for TMJ Concepts. Devices recorded under merged duplicate company entries are counted once.
Which registries list TMJ Concepts's devices?
Among its 1 most recently registered device, TMJ Concepts has devices listed in FDA PMA (1 device).
What risk classes do TMJ Concepts's devices fall under?
Among its 1 most recently registered device, the classes recorded for TMJ Concepts's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from TMJ Concepts in the registry?
The most recently registered devices listed for TMJ Concepts include TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis.