510(k) K250596

Arthrex FiberTak Suture Anchor by Arthrex, Inc. — Product Code MBI

K250596 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex FiberTak Suture Anchor". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.