510(k) K112965

NANO SUTURE ANCHOR by Linvatec Corporation D/B/A Conmed Linvatec — Product Code MBI

K112965 is an FDA 510(k) premarket notification submitted by Linvatec Corporation D/B/A Conmed Linvatec for the device "NANO SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on November 2, 2011. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Linvatec Corporation D/B/A Conmed Linvatec has at least 3 other 510(k) clearances on record.