Dallen Medical Receives FDA 510(k) Clearance For Its Tensyn Band For Syndesmosis Repair
Published: Nov 21, 2013
Dallen Medical Receives FDA 510(k) Clearance for Its Tensyn™ Band for Syndesmosis Repair
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Dallen Medical announced today that it has received FDA 510(k) clearance for its Tensyn™ band for fixation of ankle syndesmosis. This clearance follows the 510(k) FDA clearances that Dallen has received the past 18 months for both a polymer coated and non-coated Compressyn™ band and the company’s Compressyn staple for foot, ankle & hand fixation and repair.
According to David Mills, President and CEO of Dallen Medical, “This clearance reflects Dallen’s continual development of its proprietary fixation with compression technologies and an expansion of its extremities products. This clearance also positions the company for an additional submission incorporating our polymer coating and titanium versions of the Tensyn band product-line, which we expect to submit within a month.
“Together, these products will give foot and ankle orthopedic surgeons and podiatrists a variety of surgical solutions to best meet the clinical and economic demands of all busy healthcare practices.”
Dallen Medical’s innovative Compressyn and Tensyn technologies provide clinicians with next-generation fixation-with-compression solutions for use in sternal closure, small bone, and sports medicine procedures.
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 improvement in rigid fixation-with-compression solutions over current devices. Dallen’s design requirement for its products is based around the bone healing principles of Wolff’s Law, which states that bones respond to mechanical loads by changing size, shape, and structure. This guiding principle influences the design and shape of Dallen Medical’s products, today.
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.
David H. Mills, President & CEO
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