510(k) K143547

Vivorte Trabexus EB by Vivorte, Inc. — Product Code MBP

K143547 is an FDA 510(k) premarket notification submitted by Vivorte, Inc. for the device "Vivorte Trabexus EB". The FDA issued a decision of Substantially Equivalent on January 14, 2015. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Vivorte, Inc. has at least 3 other 510(k) clearances on record.