|[January 20, 2014]
Dallen Medical Receives Another FDA Clearance
SAN CLEMENTE, Calif. --(Business Wire)--
Dallen Medical of San Clemente 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
Comressyn Band for sternal closure. These milestones have positioned
the company for what we expect will be an exciting 2014," 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. 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.
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