Cleared Traditional

TRITIUM STERNAL CABLE PLATE SYSTEM

K133785 · Pioneer Surgical Technology, Inc. · Orthopedic
Jan 2014
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K133785 is an FDA 510(k) clearance for the TRITIUM STERNAL CABLE PLATE SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on January 27, 2014, 46 days after receiving the submission on December 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K133785 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2013
Decision Date January 27, 2014
Days to Decision 46 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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