Nanovis Spine, LLC receives FDA 510(k) clearance of its novel FortiCore® cervical and lumbar interbody fusion device platform
Carmel, Ind. (September 22, ) – Nanovis Spine, LLC (Nanovis) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s sterile packed FortiCore® interbody fusion devices. Unlike conventional implants comprising PEEK or sprayed titanium coating, FortiCore® implants have the benefits of a highly porous titanium scaffold engineered for strong, durable integration with a PEEK core.
Forticore implants are the first of three innovative technology platforms that Nanovis plans to bring to the spine and other orthopedic markets. “Nanovis’ mission is to lead our chosen markets with science-enhanced implants that improve lives. Based on our exiting preclinical data, the FortiCore® interbody platform certainly promises to fulfill that mission” said Matt Hedrick, Nanovis’ Chief Executive Officer.
The FortiCore® implant platform was developed with the guidance from thought leading surgeons and integrates the BioSyncTM porous scaffold licensed from SMed-TA/TD, LLC an innovative orthopedic implant development company. Members of the surgeon design team have successfully executed encouraging preclinical studies that the team expects to publish at a suitable future date.
The highly porous titanium scaffold in FortiCore® implants was designed with optimal interconnected porosity, strength, durability, and imaging properties in mind. Additional information can be found at www.nanovisinc.com.
Nanovis LLC’s vision is to become a high growth company using nanotechnology to enhance the performance of its surgical implants. The company’s broad intellectual property portfolio can be used to enhance implants to better manage the interface with bone, soft tissue, nerves, cardiovascular tissue, and to reduce colonization of implants by bacteria. For more information about Nanovis, visit www.nanovisinc.com or call Nanovis at 1-877-907-NANO.