Spine Innovation Receives FDA Clearance for Innovative Implant
Spine Innovation, LLC has reached a significant milestone, as it has secured FDA 510(k) clearance to market its LOGIC™ Titanium Implant System. This exciting development underscores the company’s commitment to advancing spine surgery and improving patient lives.
Introducing the LOGIC™ Titanium Implant System
The new LOGIC™ Implant System represents a breakthrough in spinal surgery technology. This next-generation device utilizes OsteoSync™ Ti, a proprietary, lightweight titanium lattice material developed by Sites Medical, which has been successfully implanted in over 250,000 patients since its introduction in 2014.
Design and Functionality
One of the standout features of the LOGIC™ implant is its unique design. It maintains a reduced profile during implantation but expands to more than double its size once placed, providing enhanced stability and an optimal volume for bone grafting. This evolution of design not only facilitates easier implantation but also restores disc height and maintains sagittal balance, critical for successful outcomes.
Proven Performance.
Manufactured from polyether ether ketone (PEEK) for a decade, the LOGIC™ implant has shown resilience against subsidence and expulsion, thanks to its substantial expanded footprint of 18 mm x 26 mm that covers the vertebral body.
About Spine Innovation
Founded in 2013 by a team of surgeon inventors in collaboration with Scripps Health in San Diego, CA, Spine Innovation has set out to tackle critical clinical needs in spinal surgery. Their innovative approach to implant design is a testament to the company’s dedication to advancing healthcare technologies.
Market Expansion Opportunities
The company is actively seeking U.S. sales and distribution partners to further the clinical use of the LOGIC™ implant, indicating a robust strategy for market penetration and expansion in the spinal device sector.
Contact Information for Inquiries
For further information about their products and inquiries, interested parties can contact Morris Bernstein at (770) 558-7768. While the website for Spine Innovation is available for more insights into their offerings, the media can connect through direct line communication for any immediate concerns or product inquiries.
Frequently Asked Questions
What is the LOGIC™ Implant System?
The LOGIC™ Implant System is an innovative spinal device designed for effective interbody fusion, utilizing advanced titanium technology.
How does the LOGIC™ implant enhance surgical procedures?
Its unique design facilitates a reduced profile for easy implantation, which then expands for optimal stability and improved bone graft volume.
What materials are used in the LOGIC™ implant?
The implant incorporates OsteoSync™ Ti, a pure titanium lattice material, allowing for superior strength and biocompatibility.
Why is FDA clearance significant?
FDA clearance signifies that the LOGIC™ Implant System meets stringent safety and effectiveness standards, ensuring its reliability in clinical applications.
How long has Spine Innovation been operating?
Spine Innovation, LLC was established in 2013 and has since focused on developing innovative solutions for spinal surgery challenges.
