Cleared Special

Aequalis PerFORM+ Shoulder System

K160975 · Tornier, Inc. · Orthopedic
Jun 2016
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K160975 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 June 10, 2016, 64 days after receiving the submission on April 7, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K160975 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2016
Decision Date June 10, 2016
Days to Decision 64 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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