Cleared Special

Aequalis PerFORM+ Shoulder System

K150583 · Tornier, Inc. · Orthopedic
Apr 2015
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K150583 is an FDA 510(k) clearance for the Aequalis PerFORM+ 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 April 23, 2015, 45 days after receiving the submission on March 9, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K150583 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date April 23, 2015
Days to Decision 45 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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