510(k) K230976

Arthrex Radiopaque FiberTape Cerclage sutures by Arthrex, Inc. — Product Code JDQ

K230976 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Radiopaque FiberTape Cerclage sutures". The FDA issued a decision of Substantially Equivalent on August 24, 2023. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Arthrex, Inc. has at least 10 other 510(k) clearances on record.