Iame, Inc.
Country not established
- Devices
- 1
What Iame, Inc. makes
Iame, Inc. manufactures spinal fixation systems, including the UCR Spinal System with 5.5mm and 8.0mm screws, along with associated surgical instruments designed for spinal stabilization procedures.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance process. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iame, Inc. have in the registry?
The registry currently lists 1 device for Iame, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iame, Inc.'s devices?
Among its 1 most recently registered device, Iame, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Iame, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Iame, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iame, Inc. in the registry?
The most recently registered devices listed for Iame, Inc. include UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS.