510(k) K222263

Arthrex Self Punching SwiveLock Suture Anchors by Arthrex, Inc. — Product Code MAI

K222263 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Self Punching SwiveLock Suture Anchors". The FDA issued a decision of Substantially Equivalent on Aug 26, 2022. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has 352 other 510(k) clearances on record.