510(k) K140925

ACUMED SUTURE ANCHOR SYSTEM by Acumed, LLC — Product Code MBI

K140925 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "ACUMED SUTURE ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Acumed, LLC has at least 10 other 510(k) clearances on record.