CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES

About This 510(k) Submission

K092898 is an FDA 510(k) clearance for the CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on October 19, 2009, 28 days after receiving the submission on September 21, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.