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Anjon Bremer Halo System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171863

by Anjon Holdings, LLC

Identifiers

510(k) Number
K171863 FDA 510(k)
FDA Product Code
JEC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Anjon Bremer Halo System is an external cervical fixation device that provides cervical spine immobilization and therapeutic traction for patients with cervical trauma or other neck conditions. It is a time-tested system that serves as a benchmark for similar devices in this category.

The device is manufactured by Anjon Holdings, LLC and is supplied as a component for invasive traction applications. It is a Class II medical device with FDA 510(k) clearance (K171863) under product code JEC. The system is intended for use in orthopedic settings and is available in various sizes as specified by the manufacturer.

Frequently asked questions

What is the Anjon Bremer Halo System used for?

The Anjon Bremer Halo System is an external cervical fixation device designed to provide cervical spine immobilization and therapeutic traction for patients with cervical trauma or other neck conditions in orthopedic settings.

How is the Anjon Bremer Halo System supplied?

The device is supplied as a component for invasive traction applications and is available in various sizes as specified by the manufacturer, Anjon Holdings, LLC.

What is the regulatory classification of the Anjon Bremer Halo System?

The Anjon Bremer Halo System is a Class II medical device with FDA 510(k) clearance (K171863) under product code JEC, indicating it is substantially equivalent to other devices in this category.

Is the Anjon Bremer Halo System reusable or single-use?

The device data does not specify whether the Anjon Bremer Halo System is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About - Anjon Bremer Halo System, Home - Anjon Bremer Halo System, Anjon Medical Technologies - Medical Contract Manufacturing

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anjon Holdings, LLC

Sources (1)

  • FDA 510(k) K171863 24 fields · synced Sep 22, 2026