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Bioimplants

OrthAdapt Bioimplant granted 501K clearance from U.S. FDA

Published in Medical Letter on the CDC and FDA, September 18th, 2005

Pegasus Biologics, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted 510K clearance for the OrthAdapt Bioimplant, an intelligent, adaptable biologic scaffold that fortifies and promotes tissue remodeling while retaining long-term strength.

This grants Pegasus Biologics clearance to market its bioimplants to reinforce compromised soft tissues in sports medicine, orthopedic, and spine applications.

Pegasus Biologics, Inc. develops novel bioimplants using proprietary technologies.

This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports. Copyright 2005, Medical...

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