SBi’s S.T.A.R. Total Ankle Replacement System Receives FDA Approvable Letter

Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone & joint sector of the orthopedics industry, announced today that an ‘Approvable Letter’ has been received from the U.S. Food and Drug Administration (FDA) for the Scandinavian Total Ankle Replacement system (S.T.A.R. Ankle). The Approvable Letter states that the FDA has concluded its review of the S.T.A.R. Ankle PMA application.

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Filed under: Bones on March 8th, 2009