510(k) K223589

Grappler Suture Anchor R3FLEX IOL System by Paragon 28, Inc. — Product Code MBI

K223589 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Grappler Suture Anchor R3FLEX IOL System". The FDA issued a decision of Substantially Equivalent on March 3, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Paragon 28, Inc. has at least 10 other 510(k) clearances on record.