Cleared Traditional

TORNIER CEMENT RESTRICTOR

K061824 · Tornier · Orthopedic
Sep 2006
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K061824 is an FDA 510(k) clearance for the TORNIER CEMENT RESTRICTOR, a Cement Obturator (Class II — Special Controls, product code LZN), submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on September 14, 2006, 78 days after receiving the submission on June 28, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K061824 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2006
Decision Date September 14, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZN — Cement Obturator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300