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Dallen Medical files FDA 510(k) application for Compressyn staple implant

US-based orthopedics services provider Dallen Medical has filed 510(k) application with the US Food and Drug Administration (FDA) for individually packaged, sterile Compressyn staple implants.

The Compressyn staple implant delivers superior fixation with compression in sternal closure, small bone, and sports med applications.

Dallen Medical president and CEO David H Mills noted once cleared, this submission will allow the company to offer physicians the highest level of rigidity and compression with its proprietary Compressyn staple, but also at a price point to meet every hospital and surgery center’s budget.

"As we have communicated to our investors, we will continue to expand the Compressyn family of products so that we can improve patient outcomes and thereby reduce costs to the healthcare system," Mills added.

In February 2013, the company received approval for the Compressyn staple as a reusable system for small bone fixation, specifically in foot, ankle and hand applications.

In addition, the company had received three FDA clearances.