510(k) K221232

Univers Revers Humeral Cup Implant by Arthrex, Inc. — Product Code HSD

K221232 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Univers Revers Humeral Cup Implant". The FDA issued a decision of Substantially Equivalent on May 19, 2022. 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.