510(k) K121890

GENESYS PRESSFT SUTURE ANCHOR by Linvatec Corporation D/B/A Conmed Linvatec — Product Code MAI

K121890 is an FDA 510(k) premarket notification submitted by Linvatec Corporation D/B/A Conmed Linvatec for the device "GENESYS PRESSFT SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on August 22, 2012. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Linvatec Corporation D/B/A Conmed Linvatec has at least 3 other 510(k) clearances on record.