HC Biologics, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What HC Biologics, LLC makes
HC Biologics, LLC manufactures spinal fixation systems, including the Osteopoint Spinal Fixation System and PEEK-based interbody cages for cervical and lumbar applications. These products are designed for use in surgical procedures to stabilize the spine, with specific models tailored for different spinal regions.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
HC Biologics Osteopoint Spinal Fixation System Ref K250092
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does HC Biologics, LLC have in the registry?
The registry currently lists 2 devices for HC Biologics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list HC Biologics, LLC's devices?
Among its 2 most recently registered devices, HC Biologics, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do HC Biologics, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for HC Biologics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from HC Biologics, LLC in the registry?
The most recently registered devices listed for HC Biologics, LLC include HC Biologics Osteopoint Spinal Fixation System and HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES.