Cleared Traditional

Cardinal Health External Fixation System

K150579 · Cardinalhealth · Orthopedic
Apr 2015
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K150579 is an FDA 510(k) clearance for the Cardinal Health External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on April 29, 2015, 51 days after receiving the submission on March 9, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K150579 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date April 29, 2015
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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