Cleared Traditional

SteriTrak

K203605 · Arbutus Medical, Inc. · Orthopedic

Apr 2021

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K203605 is an FDA 510(k) clearance for the SteriTrak, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Arbutus Medical, Inc. (Vancouver, CA). The FDA issued a Cleared decision on April 23, 2021, 134 days after receiving the submission on December 10, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K203605 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2020
Decision Date	April 23, 2021
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF