510(k) K090835

CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR by Linvatec Corp. — Product Code MAI

K090835 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR". The FDA issued a decision of Substantially Equivalent on June 22, 2009. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Linvatec Corp. has at least 10 other 510(k) clearances on record.