SAN CLEMENTE, Calif.--(EON: Enhanced Online News)--Dallen Medical has filed its FDA 510(k) application for individually packaged, sterile Compressyn™ staple implants. Clearance of the Compressyn staple was already received in February of this year as a reusable system for small bone fixation, specifically in foot, ankle and hand applications. With three FDA clearances already received, this continues the company’s plan to expand its Compressyn family of products.
“Once cleared, this submission will allow Dallen to offer physicians the highest level of rigidity and compression with our proprietary Compressyn staple, but also at a price point to meet every hospital and surgery center’s budget. As we have communicated to our investors, we will continue to expand the Compressyn family of products so that we can improve patient outcomes and thereby reduce costs to the healthcare system,” Dallen Medical president and CEO, David H. Mills said.
Dallen Medical's patented Compressyn™ technology offers significant improvement over existing products by delivering superior fixation with compression in sternal closure, small bone, and sports med applications. This should result in better patient outcomes, resulting in cost savings and reductions in length of stay.
For more information, visit www.dallenmedical.com
About Dallen Medical
Dallen Medical is dedicated to the development of optimized bone fixation and repair technologies and devices. The company’s mission is to provide significant improvements in rigid fixation-with-compression solutions over current devices. Equally significant, all of the company’s developmental efforts, technologies, and products adhere to the AO Foundation’s Principles of Orthopedics. The overriding intent of all of Dallen Medical’s innovative, cost-effective devices is to facilitate improved patient outcomes and shorter hospital stays—resulting in meaningful clinical benefits for patients, physicians and hospitals, worldwide.