Orthobond Secures De Novo Classification Grant for First-in-Class Antibacterial Surface Treatment Applied to a Spinal Device
Orthobond Corporation , a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, announced today that the U.S. Food and Drug Administration (FDA) granted its De Novo marketing request for the use of Ostaguard™, its proprietary antibacterial surface treatment, on a permanent medical device.
- Orthobond Corporation , a leader in covalently-bound antibacterial surface technologies with broad applications in the medical device industry, announced today that the U.S. Food and Drug Administration (FDA) granted its De Novo marketing request for the use of Ostaguard™, its proprietary antibacterial surface treatment, on a permanent medical device.
- Numerous studies have shown between 70-100% of explanted hardware from failed joint implants have some level of contamination from different sources.
- Orthobond pioneered a method to covalently-bond its antibacterial molecule to the surface of implants.
- The proprietary surface technology is applied during the manufacturing process prior to packaging and sterilization.