Cleared Traditional

Anjon Bremer Halo System

K193256 · Anjon Holdings, LLC · Orthopedic

Mar 2020

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K193256 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 2, 2020, 97 days after receiving the submission on November 26, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K193256 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2019
Decision Date	March 02, 2020
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF