510(k) K201522

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System by Arthrex, Inc. — Product Code HTN

K201522 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Syndesmosis TightRope XP Buttress Plate Implant System". The FDA issued a decision of Substantially Equivalent on Sep 3, 2020. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has 352 other 510(k) clearances on record.