Cleared Traditional

Cardinal Health Trochanteric IM Nail System

K150769 · Cardinalhealth · Orthopedic
Dec 2015
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K150769 is an FDA 510(k) clearance for the Cardinal Health Trochanteric IM Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on December 14, 2015, 265 days after receiving the submission on March 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K150769 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2015
Decision Date December 14, 2015
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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