Cleared Special

AEQUALIS FLEX REVIVE Shoulder System

K191318 · Tornier, Inc. · Orthopedic
Jun 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191318 is an FDA 510(k) clearance for the AEQUALIS FLEX REVIVE Shoulder System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on June 14, 2019, 30 days after receiving the submission on May 15, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K191318 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2019
Decision Date June 14, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3660

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