510(k) K153558

Ventix Suture Anchor by Biomet Manufacturing Corp — Product Code MBI

K153558 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "Ventix Suture Anchor". The FDA issued a decision of Substantially Equivalent on April 21, 2016. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.