510(k) K092898

CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES by Conmed Linvatec — Product Code MAI

K092898 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES". The FDA issued a decision of Substantially Equivalent on October 19, 2009. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Conmed Linvatec has at least 10 other 510(k) clearances on record.