Cleared Traditional

Arthrex Univers Revers Shoulder Prosthesis System

K161782 · Arthrex, Inc. · Orthopedic
Nov 2016
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K161782 is an FDA 510(k) clearance for the Arthrex Univers Revers Shoulder Prosthesis System, 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 November 21, 2016, 145 days after receiving the submission on June 29, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K161782 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2016
Decision Date November 21, 2016
Days to Decision 145 days
Submission Type Traditional
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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