510(k) K161782

Arthrex Univers Revers Shoulder Prosthesis System by Arthrex, Inc. — Product Code HSD

K161782 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Univers Revers Shoulder Prosthesis System". The FDA issued a decision of Substantially Equivalent on November 21, 2016. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Arthrex, Inc. has at least 10 other 510(k) clearances on record.