The approval enables Dallen to offer physicians the highest level of rigidity and compression with their proprietary Compressyn Staple.
Dallen Medical received FDA 510(k) clearance for its individually packaged, sterile Compressyn Staple implants. With FDA clearances for both its Compressyn Staple and Tensyn Band for syndesmosis repair, the company has executed its plan for a platform of extremities products built around its Compressyn and Tensyn technologies.
“This clearance allows 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. In the last twelve months, Dallen has received three FDA clearances and initiated commercialization of its first product, the Compressyn Band for sternal closure. These milestones have positioned the company for what we expect will be an exciting 2014,” says David H. Mills, Dallen Medical president and CEO.
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.
Source: Dallen Medical