510(k) K262047

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

K262047 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Grappler Suture Anchor System". The FDA issued a decision of Substantially Equivalent on August 3, 2026. 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.