510(k) K232457

Q-FIX ULTRA All-Suture Anchor by Smith & Nephew — Product Code MBI

K232457 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "Q-FIX ULTRA All-Suture Anchor". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew has at least 10 other 510(k) clearances on record.