Cleared Traditional

Anjon Bremer Halo System

K171863 · Anjon Holdings, LLC · Orthopedic

Mar 2018

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K171863 is an FDA 510(k) clearance for the Anjon Bremer Halo System, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Anjon Holdings, LLC (Jacksonville, US). The FDA issued a Cleared decision on March 19, 2018, 270 days after receiving the submission on June 22, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K171863 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2017
Decision Date	March 19, 2018
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF