Cleared Traditional

JAZZ SYSTEM

K121541 · Implanet, S.A. · Orthopedic
Sep 2012
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K121541 is an FDA 510(k) clearance for the JAZZ SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Implanet, S.A. (Philedelphia, US). The FDA issued a Cleared decision on September 13, 2012, 112 days after receiving the submission on May 24, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K121541 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2012
Decision Date September 13, 2012
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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