Nexus CMF, LLC
Country not established
- Devices
- 3
What Nexus CMF, LLC makes
Nexus CMF, LLC manufactures custom prostheses for temporomandibular joint (TMJ) reconstruction, including systems for the TMJ fossa-eminence and condylar regions. These devices are designed to restore anatomical structure and function in patients requiring surgical intervention for TMJ defects or trauma. The prostheses are intended for use in complex craniofacial and maxillofacial procedures where natural joint surfaces are replaced or augmented.
The company’s TMJ prostheses are classified as Class III medical devices under FDA regulations and require Premarket Approval (PMA) authorization. These devices are listed in the FDA’s PMA registry, reflecting their status as high-risk, life-sustaining or life-supporting products. Nexus CMF, LLC operates from the United States, adhering to domestic regulatory requirements for Class III devices.
Catalogue
TruVision Single-Use 1.9mm Arthroscopy System Ref K260156
Regimes: 510(k) Registry: 510(k)- Regimes: PMA Registry: PMA
Tmj Fossa-Eminence Prosthesis System Ref P000035
Regimes: CE MDR PMA Registry: PMA
Frequently asked questions
How many devices does Nexus CMF, LLC have in the registry?
The registry currently lists 3 devices for Nexus CMF, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nexus CMF, LLC's devices?
Among its 3 most recently registered devices, Nexus CMF, LLC has devices listed in FDA 510(k) (1 device) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nexus CMF, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nexus CMF, LLC's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Nexus CMF, LLC in the registry?
The most recently registered devices listed for Nexus CMF, LLC include TruVision Single-Use 1.9mm Arthroscopy System, TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM and TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM.