Excited about
Us Too!
With over 20 years of experience and 2 million devices implanted globally, NovaBone's regenerative matrices are proven to enhance patient outcomes. Our innovative portfolio offers growth opportunities for partners across multiple indications. Join us in accelerating new bone formation. We're with you every step of the way.
Regulatory Advantage
- First to receive US FDA osteostimulative claim
- 31 medical device 510(k)s cleared by US FDA
- Valid EU MDD1; pursuing EU MDR
- Registrations in 46 countries
Innovation & Quality Excellence
- ISO 13485 certified
- MDSAP certification
- 9 utility patents
Manufacturing Expertise
- Manufactured in Alachua, Florida, USA
- 30,000 sq ft of manufacturing space
- 8,000 sq ft of ISO Class 7 clean rooms
1 NovaBone’s currently CE-certified products are placed on the EU market per EU MDD. The associated CE certificates are considered to remain valid until December 31, 2027, pursuant to regulation (EU) 2023/607. NovaBone’s Confirmation Letter is available upon request.