Tepha has received a number of FDA 510(k) clearances for medical devices made from its lead biomaterial, TephaFLEX® polymer. The first was a clearance of an absorbable monofilament suture, which then provided a foundation for the Company and its partners to develop additional devices using the 510(k) path. Since that time, regulatory clearances have been received for a monofilament surgical mesh, a tissue separation film, and other products by the Company. In the same time frame, Tepha’s corporate partners have also been receiving 510(k) clearances of TephaFLEX® based devices.
Tepha often collaborates with leading medical device manufacturing companies which have products on the market, or products in development, that would benefit from incorporating Tepha’s absorbable biomaterials technology. The company is able to develop and manufacture medical device components and finished goods made from its proprietary biomaterials.
For more information on Tepha’s partnering activities, please email us at firstname.lastname@example.org.