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Dallen Medical Files 510(k) for FDA Clearance on Tensyn Band for Syndemosis Repair
7/23/2013 9:44:43 AM
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Dallen Medical announced that it has filed a 510(k) to obtain FDA clearance for a third product-line, its proprietary Tensyn™ Band for syndesmosis repair. This filing follows the 510(k) FDA clearances that Dallen has received over the past 18 months for its Compressyn™ Band (for sternal closure after open heart procedures) and Compressyn™ Staple (for foot, ankle and hand fixation; and repair).
According to David Mills, President and CEO of Dallen Medical, “With this submission, we look forward to expanding our banding technology and to offering foot and ankle orthopedic surgeons and podiatrists another exciting new product.”
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 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.
David H. Mills, 949-218-0030
President & CEO
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