510(k) K221485

Arthrex FiberTape and TigerTape Cerclage Sutures by Arthrex, Inc. — Product Code HTN

K221485 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex FiberTape and TigerTape Cerclage Sutures". The FDA issued a decision of Substantially Equivalent on August 22, 2022. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.