Cleared Special

Univers Revers Humeral Cup Implant

K221232 · Arthrex, Inc. · Orthopedic
May 2022
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K221232 is an FDA 510(k) clearance for the Univers Revers Humeral Cup Implant, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 19, 2022, 20 days after receiving the submission on April 29, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K221232 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2022
Decision Date May 19, 2022
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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