Cleared Traditional

K172830 - Double Medical Femoral Nail System (FDA 510(k) Clearance)

K172830 · Double Medical Technology, Inc. · Orthopedic device

Aug 2018

Decision

340d

Days

Class 2

Risk

K172830 is an FDA 510(k) clearance for the Double Medical Femoral Nail System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K172830 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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