510(k) K090186

CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES by Linvatec Corp. — Product Code MAI

K090186 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES". The FDA issued a decision of Substantially Equivalent on April 10, 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.