Cleared Traditional

SYNTHES STERNAL ZIPFIX SYSTEM

K110789 · Synthes (Usa) · Orthopedic
Jul 2011
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K110789 is an FDA 510(k) clearance for the SYNTHES STERNAL ZIPFIX SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 28, 2011, 128 days after receiving the submission on March 22, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K110789 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2011
Decision Date July 28, 2011
Days to Decision 128 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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