Cleared Special

AEQUALIS SHOULDER SYSTEM

K063081 · Tornier · Orthopedic
Nov 2006
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K063081 is an FDA 510(k) clearance for the AEQUALIS SHOULDER SYSTEM, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on November 9, 2006, 30 days after receiving the submission on October 10, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K063081 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2006
Decision Date November 09, 2006
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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