Cleared Traditional

Double Medical Femoral Nail System

K172830 · Double Medical Technology, Inc. · Orthopedic
Aug 2018
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K172830 is an FDA 510(k) clearance for the Double Medical Femoral Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on August 24, 2018, 340 days after receiving the submission on September 18, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K172830 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2017
Decision Date August 24, 2018
Days to Decision 340 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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