Eden Spine, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Eden Spine, LLC makes
Eden Spine, LLC manufactures vertebral body replacement systems, including the GIZA® Vertebral Body Replacement and the Sphynx™, designed for spinal reconstruction and stabilization procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Giza(R) Vertebral Body Replacement Ref K112429
Regimes: 510(k) Registry: 510(k)Sphynx™ Ref K160982
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Eden Spine, LLC have in the registry?
The registry currently lists 2 devices for Eden Spine, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eden Spine, LLC's devices?
Among its 2 most recently registered devices, Eden Spine, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Eden Spine, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eden Spine, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eden Spine, LLC in the registry?
The most recently registered devices listed for Eden Spine, LLC include GIZA(R) VERTEBRAL BODY REPLACEMENT and Sphynx™.