University of Utah, Department of Orthopaedics
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- Devices
- 2
What University of Utah, Department of Orthopaedics makes
The University of Utah’s Department of Orthopaedics develops orthopaedic fixation devices, including the Bone Bolt System for bone stabilization and the CoAptix S System for fracture management.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The department operates within the United States.
Catalogue
Bone Bolt System Ref K230867
Regimes: 510(k) Registry: 510(k)CoAptix S System Ref K252699
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does University of Utah, Department of Orthopaedics have in the registry?
The registry currently lists 2 devices for University of Utah, Department of Orthopaedics. Devices recorded under merged duplicate company entries are counted once.
Which registries list University of Utah, Department of Orthopaedics's devices?
Among its 2 most recently registered devices, University of Utah, Department of Orthopaedics has devices listed in FDA 510(k) (2 devices).
What risk classes do University of Utah, Department of Orthopaedics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for University of Utah, Department of Orthopaedics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from University of Utah, Department of Orthopaedics in the registry?
The most recently registered devices listed for University of Utah, Department of Orthopaedics include Bone Bolt System and CoAptix S System.