510(k) K231857

Arthrex TightRope II by Arthrex, Inc. — Product Code MBI

K231857 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex TightRope II". The FDA issued a decision of Substantially Equivalent on August 8, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.