Southern California medical device maker Dallen Medical has received FDA 510(k) clearance for the Compressyn™ Staple for small bone fixation, specifically in foot, ankle, and hand applications. With the company’s Compressyn™ Band for sternal closure already FDA cleared, this milestone expands Dallen’s family of Compressyn products.
Dallen Medical President and CEO, David H. Mills said; “We are very pleased to receive this clearance and are excited about the potential for our Compressyn Staple to help improve patient outcomes and reduce costs for the healthcare system. The new Compressyn Staple uniquely offers physicians the ease of a staple with a new standard of rigid compression for small bone fixation”.
Dallen Medical says its patented Compressyn™ technology offers significant improvement over existing products by delivering superior fixation with dynamic compression in sternal closure, small bone, and sports medicine applications.