510(k) K243344

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures by Arthrex, Inc. — Product Code JDQ

K243344 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures". The FDA issued a decision of Substantially Equivalent on February 20, 2025. 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.