Cleared Special

AEQUALIS HUMERAL PLATE

K063551 · Tornier · Orthopedic

Dec 2006

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K063551 is an FDA 510(k) clearance for the AEQUALIS HUMERAL PLATE, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on December 22, 2006, 28 days after receiving the submission on November 24, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K063551 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2006
Decision Date	December 22, 2006
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030