Balmoral Medical, LLC
Country not established
- Devices
- 1
What Balmoral Medical, LLC makes
Balmoral Medical, LLC manufactures the ROSA Knee System, an orthopedic surgical navigation platform integrated with ultrasound imaging to assist in knee procedures. The system is designed to enhance precision during joint replacement surgeries by providing real-time imaging and guidance. It supports intraoperative planning and alignment adjustments for improved surgical outcomes.
The ROSA Knee System is classified as a Class II medical device under FDA regulations and requires 510(k) clearance for market authorization. The company operates from the United States, where its devices are listed with the FDA.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Balmoral Medical, LLC have in the registry?
The registry currently lists 1 device for Balmoral Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Balmoral Medical, LLC's devices?
Among its 1 most recently registered device, Balmoral Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Balmoral Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Balmoral Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Balmoral Medical, LLC in the registry?
The most recently registered devices listed for Balmoral Medical, LLC include ROSA Knee System with UltraSound Imaging Platform (USIP).