510(k) K233260

Univers Revers CA Head and Adapter by Arthrex, Inc. — Product Code HSD

K233260 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Univers Revers CA Head and Adapter". The FDA issued a decision of Substantially Equivalent on February 12, 2024. 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.