510(k) K243742

Arthrex DynaNite Nitinol Staples by Arthrex, Inc. — Product Code JDR

K243742 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex DynaNite Nitinol Staples". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.