CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES

About This 510(k) Submission

K090186 is an FDA 510(k) clearance for the CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on April 10, 2009, 74 days after receiving the submission on January 26, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.