Cleared Traditional

AEQUALIS RESURFACING HEAD

K062661 · Tornier · Orthopedic
Dec 2006
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K062661 is an FDA 510(k) clearance for the AEQUALIS RESURFACING HEAD, 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 December 22, 2006, 106 days after receiving the submission on September 7, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K062661 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2006
Decision Date December 22, 2006
Days to Decision 106 days
Submission Type Traditional
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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