HC Biologics, LLC - FDA 510(k) Cleared Devices

HC Biologics, LLC is a medical device company specializing in biologics, spine, and orthopedic solutions. The company operates with a manufacturing facility in Miami, US, and serves healthcare professionals and patients globally across nearly 50 countries.

HC Biologics has received 2 FDA 510(k) clearances from 2 total submissions. The company's regulatory focus is entirely on orthopedic devices, with clearances spanning 2025 to 2026. Recent cleared devices include spinal fixation systems and PEEK cage implants for cervical and lumbar applications.

The company's product portfolio encompasses allografts, demineralized bone matrices, sports medicine allografts, structural allografts, and spinal implant systems. HC Biologics also offers biologic solutions including autologous therapies, biological matrices, and hemostats designed to support tissue regeneration and surgical outcomes.

Explore the complete list of HC Biologics FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.