Dallen Medical Files Syndesmosis Tensyn™ Band 510(k)

Dallen Medical has announced that it has submitted an FDA 510(k) application as it seeks clearance for its proprietary Tensyn™ Band for syndesmosis repair.

Background

We’ve covered previous FDA clearances for Dallen products, including its Compressyn™ Band (for sternal closure after open heart procedures) and Compressyn™ Staple (for foot, ankle and hand fixation and repair).

The company’s newly issued press release, which says very little about the Tensyn band device per se, reiterates its mission is to provide significant improvements in rigid fixation-with-compression solutions over current devices.

But come on guys, if you’re going to tantalise us with a press release, let us have a look at the product concept.

Company comments

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.”

Source: Dallen Medical, Inc., Business Wire