510(k) K190333

Paradigm All-Suture Anchor 1.8mm, White/Black #2 by Conmed Corporation — Product Code MBI

K190333 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Paradigm All-Suture Anchor 1.8mm, White/Black #2". The FDA issued a decision of Substantially Equivalent on Mar 18, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has 82 other 510(k) clearances on record.