Cleared Traditional

Tritium Sternal Cable Plate System

K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic
Mar 2020
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K193468 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. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on March 12, 2020, 87 days after receiving the submission on December 16, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K193468 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2019
Decision Date March 12, 2020
Days to Decision 87 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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