Spine Innovation LLC, a US-based medical device startup that develops novel interbody fusion implants, announced on Monday that it has received FDA 510(k) approval to market the LOGIC Titanium Implant System.
The LOGIC Implant System is the next generation LOGIC implant incorporating OsteoSync Ti, a patented, pure titanium lattice material from Sites Medical which has been implanted in more than 250,000 patients since 2014.
According to Spine Innovation, the patented LOGIC implant is designed with a reduced profile during implantation that more than doubles in size during expansion for maximum stability and bone graft volume. Manufactured from polyether ether ketone (PEEK), the design has been used successfully in the United States for 10 years.
The implant restores disc height and sagittal balance while resisting subsidence and expulsion due to an 18 mm x 26 mm expanded footprint spanning the vertebral body and is now available in OsteoSync Ti.
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Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval