510(k) K261632

Thunderbolt System by Responsive Arthroscopy, Inc. — Product Code MBI

K261632 is an FDA 510(k) premarket notification submitted by Responsive Arthroscopy, Inc. for the device "Thunderbolt System". The FDA issued a decision of Substantially Equivalent on July 20, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Responsive Arthroscopy, Inc. has at least 10 other 510(k) clearances on record.