Novabone Products, LLC - FDA 510(k) Cleared Devices

Novabone Products, LLC develops biomaterials for regenerative medicine, specializing in bioactive synthetic bone grafts and osteobiologic products. The company serves dental and orthopedic surgeons with innovative solutions that harness the body's natural healing process. Based in Alachua, Florida, Novabone has been advancing bone graft technology since 2002.

The company maintains a strong FDA 510(k) regulatory record with 30 cleared devices from 30 total submissions. All submissions have received clearance, demonstrating consistent regulatory success. Novabone's portfolio spans orthopedic and dental applications, with devices ranging from putty formulations to composite delivery systems. The company's latest FDA 510(k) clearance was received in 2024, confirming ongoing product development and market activity.

Novabone's cleared devices include bioactive putty formulations, composite bone grafts, minimally invasive delivery systems, and bioactive strips. Recent clearances reflect the company's focus on expanding delivery options and clinical applications across spine, foot and ankle, and general orthopedic surgery. The company also markets products for dental regeneration and periodontal applications.

Explore the full list of Novabone's FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.

Regulatory submissions have been managed by Secure BioMed Evaluations, Geyser Medical Consulting and Bruder Consulting & Venture Group.