Cleared Traditional

Tritium Sternal Cable Plate System

K150581 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic
Jun 2015
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K150581 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 June 4, 2015, 87 days after receiving the submission on March 9, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K150581 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date June 04, 2015
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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