Cleared Traditional

DIGIFIX EXTERNAL FIXATION SYSTEM

K132731 · Virak Orthopedic Research, LLC · Orthopedic

Jan 2014

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K132731 is an FDA 510(k) clearance for the DIGIFIX EXTERNAL FIXATION SYSTEM, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Virak Orthopedic Research, LLC (Bartlett, US). The FDA issued a Cleared decision on January 10, 2014, 129 days after receiving the submission on September 3, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K132731 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2013
Decision Date	January 10, 2014
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF