Cleared Special

KIT MENDEC SPINE AND DELIVERY SYSTEM

K062452 · Tecres S.P.A. · Orthopedic
Sep 2006
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K062452 is an FDA 510(k) clearance for the KIT MENDEC SPINE AND DELIVERY SYSTEM, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on September 21, 2006, 30 days after receiving the submission on August 22, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K062452 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2006
Decision Date September 21, 2006
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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