Cleared Special

DigiFix Sterile Kit

K192465 · Virak Orthopedics, LLC · Orthopedic

Oct 2019

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K192465 is an FDA 510(k) clearance for the DigiFix Sterile Kit, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Virak Orthopedics, LLC (Harrison, US). The FDA issued a Cleared decision on October 10, 2019, 31 days after receiving the submission on September 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K192465 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2019
Decision Date	October 10, 2019
Days to Decision	31 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF