Soma Blue, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Soma Blue, Inc. makes
Soma Blue, Inc. manufactures customizable orthopedic implants, including the ELITE CUSTOM line, designed for surgical applications in bone reconstruction. The company also produces the VITALITY SYSTEM, a modular device intended for spinal stabilization procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Elite Custom Ref K993142
Regimes: 510(k) Registry: 510(k)Vitality System Ref K993143
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Soma Blue, Inc. have in the registry?
The registry currently lists 2 devices for Soma Blue, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soma Blue, Inc.'s devices?
Among its 2 most recently registered devices, Soma Blue, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Soma Blue, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Soma Blue, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Soma Blue, Inc. in the registry?
The most recently registered devices listed for Soma Blue, Inc. include ELITE CUSTOM and VITALITY SYSTEM.