Cleared Traditional

AEQUALIS SHOULDER SYSTEM

K111902 · Tornier · Orthopedic
Nov 2011
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K111902 is an FDA 510(k) clearance for the AEQUALIS SHOULDER SYSTEM, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on November 3, 2011, 121 days after receiving the submission on July 5, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K111902 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2011
Decision Date November 03, 2011
Days to Decision 121 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

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