Orbbo Surgical, LLC
United StatesFDA applicant, unverified
- Devices
- 4
What Orbbo Surgical, LLC makes
Orbbo Surgical, LLC manufactures spinal fixation systems, including the Kepler II and Hubble II for lumbar and thoracic applications, as well as the Kepler I Cervical Plate System for cervical spine stabilization. The Hubble I System is designed for internal fixation in spinal surgeries.
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
Kepler II Ref K163265
Regimes: 510(k) Registry: 510(k)Hubble II Ref K163180
Regimes: 510(k) Registry: 510(k)Kepler I Cervical Plate System Ref K163602
Regimes: 510(k) Registry: 510(k)Hubble I System Ref K163566
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orbbo Surgical, LLC have in the registry?
The registry currently lists 4 devices for Orbbo Surgical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbbo Surgical, LLC's devices?
Among its 4 most recently registered devices, Orbbo Surgical, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Orbbo Surgical, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Orbbo Surgical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orbbo Surgical, LLC in the registry?
The most recently registered devices listed for Orbbo Surgical, LLC include Kepler II, Hubble II, Kepler I Cervical Plate System and Hubble I System.