510(k) K222161

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

K222161 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Knotless FiberTak Biceps Suture Anchor". The FDA issued a decision of Substantially Equivalent on Aug 11, 2022. 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 352 other 510(k) clearances on record.