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Dallen granted FDA clearance for small bone fixation system
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Dallen Medical recently announced it has received FDA 510(k) clearance for a new version of the Compressyn Staple Delivery System for small bone fixation.
This disposable version of the Compressyn system is aimed at providing medical professionals a less expensive alternative to the reusable system, which the company touts as the only rigid compression fixation technology that delivers continual, dynamic compression for small bone fixation.
The Compressyn system provides active tension via a rigid staple that springs into position upon delivery to provide strong, consistent compression, according to a company press release. The system’s design is meant to minimize the risk of splaying, improve patient outcomes and reduce both treatment cost and length of hospital stay.
Dallen announced that it has also filed an FDA submission for an acromioclavicular ligament repair device for shoulder separation, adding to the Tensyn band line of products, according to the release.