Cerabio, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Cerabio, LLC makes
Cerabio, LLC manufactures synthetic bone graft substitutes, including APATIGHT HA-BONE and APATIGHT-TCP, designed for orthopedic and spinal applications to promote bone healing and integration.
These products are regulated as Class II medical devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Apatight Ha-Bone Graft Substitute Ref K013960
Regimes: 510(k) Registry: 510(k)Apatight-Tcp Bone Graft Substitute Ref K013966
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cerabio, LLC have in the registry?
The registry currently lists 2 devices for Cerabio, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cerabio, LLC's devices?
Among its 2 most recently registered devices, Cerabio, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Cerabio, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cerabio, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cerabio, LLC in the registry?
The most recently registered devices listed for Cerabio, LLC include APATIGHT HA-BONE GRAFT SUBSTITUTE and APATIGHT-TCP BONE GRAFT SUBSTITUTE.