510(k) K210050

Augmented VaultLock Glenoid by Arthrex, Inc. — Product Code KWS

K210050 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Augmented VaultLock Glenoid". The FDA issued a decision of Substantially Equivalent on June 7, 2021. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Arthrex, Inc. has at least 10 other 510(k) clearances on record.