Cleared Special

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST

K092773 · Tecres S.P.A. · Orthopedic
Nov 2009
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K092773 is an FDA 510(k) clearance for the CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on November 24, 2009, 76 days after receiving the submission on September 9, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K092773 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2009
Decision Date November 24, 2009
Days to Decision 76 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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