Cleared Traditional

Aequalis Flex Revive Shoulder System

K181420 · Tornier, Inc. · Orthopedic

Sep 2018

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K181420 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 September 20, 2018, 112 days after receiving the submission on May 31, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K181420 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2018
Decision Date	September 20, 2018
Days to Decision	112 days
Submission Type	Traditional
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