Nextremity Solutions™ Obtains ISO 13485 Certification and CE Mark for Nextra™ Hammertoe Correction System
COLTS NECK, NJ, 29 November 2011 – Nextremity Solutions, LLC announced it has obtained ISO 13485 Certification of its Quality Management System and CE Mark Certification of the NEXTRA™ Hammertoe Correction System. The NEXTRA System is a key component to the company’s forefoot reconstruction portfolio and was introduced for limited release at the American Orthopaedic Foot & Ankle Society Congress, July 13-15 in Keystone, Colorado. The global launch of the product will commence in early 2012. Arthur Alfaro, President & CEO, commented that, “We are very proud to have achieved ISO certification at such an early stage in the company’s development and conform to a global quality standard for medical devices. The additional CE Mark Certification of the NEXTRA Hammertoe System allows us to now initiate the global commercial release of our First-in-Class surgical procedure kit and implant for treating a foot deformity which affects 10 to 20% of the population. The company will now mobilize its resources to train orthopaedic surgeons, podiatric surgeons and trauma surgeons in what we believe will be a game changing product. NEXTRA is our first product in a series of highly differentiated surgical solutions for one of the fastest growing sectors in the medical device industry.” About Nextremity Solutions, LLC Nextremity Solutions is a privately held medical-device company offering a novel approach to the surgical correction of small bone deformity, degeneration and trauma, founded by surgeons who are committed to the development of medical implants that will provide repeatable and superior patient outcomes. Nextra™ Hammertoe Correction System and Nextra™ Hammertoe Correction Implant are trademarks of Nextremity Solutions, LLC. For further information, visit www.nextremitysolutions.com or call 574-635-3023.