OrthoPediatrics’ eLLi Surgical Device Granted FDA Breakthrough Designation

OrthoPediatrics Corp., a leading company specializing in pediatric orthopedics, has announced that its new eLLi surgical device has been granted the "Breakthrough Device" Designation by the Food and Drug Administration (FDA). The eLLi device, designed to address severe pathology associated with Early Onset Scoliosis (EOS), offers a non-invasive means of extending growing rods with increased force, enhanced mechanical reliability, and superior distraction precision, addressing safety concerns associated with current technology. This breakthrough designation signifies the device's potential to provide more effective treatment for life-threatening conditions, expediting its development, assessment, and review process while upholding stringent regulatory standards.

David Bailey, OrthoPediatrics’ President and CEO, expressed pride in the team's achievement, emphasizing the innovative nature of the eLLi device and its significant contribution to pediatric orthopedics. With a commitment to continuous innovation and advancing healthcare for children worldwide, OrthoPediatrics aims to provide surgeons with advanced technologies to improve patient outcomes. Established in 2006, OrthoPediatrics is dedicated exclusively to pediatric orthopedics, offering a comprehensive product line that addresses trauma, deformity, scoliosis, and sports medicine procedures. With a global sales organization focused on pediatric orthopedics, OrthoPediatrics distributes its products in the United States and over 70 countries worldwide.

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