Cleared Traditional

UNITY HUMERAL PLATE

K060545 · Tornier · Orthopedic

Apr 2006

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K060545 is an FDA 510(k) clearance for the UNITY HUMERAL PLATE, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Tornier (St. Ismier, FR). The FDA issued a Cleared decision on April 21, 2006, 51 days after receiving the submission on March 1, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K060545 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2006
Decision Date	April 21, 2006
Days to Decision	51 days
Submission Type	Traditional
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