Anjon Bremer Halo System

Component, Traction, Invasive

Anjon Holdings, LLC

The following data is part of a premarket notification filed by Anjon Holdings, Llc with the FDA for Anjon Bremer Halo System.

Pre-market Notification Details

• Device ID: K171863
• 510k Number: K171863
• Device Name: Anjon Bremer Halo System
• Classification: Component, Traction, Invasive
• Applicant: Anjon Holdings, LLC 4801 Dawin Rd Jacksonville, FL 32207
• Contact: Tommy Mitchell
• Correspondent: John Kapitan; Kapstone Medical P.O. Box 969 Leicester, NC 28748
• Product Code: JEC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-22
• Decision Date: 2018-03-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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