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FDA 510(k)

Anjon Bremer Halo System

K-Number: K193256 · 2020-03-02

ApplicantAnjon Holdings, LLC
Decision Date2020-03-02
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anjon Bremer Halo System is a medical device manufactured by Anjon Holdings, LLC. It received FDA 510(k) clearance on 2020-03-02 under approval number K193256. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anjon Bremer Halo System?

Anjon Bremer Halo System is a medical device that received FDA 510(k) clearance on 2020-03-02. It is manufactured by Anjon Holdings, LLC. The 510(k) number is K193256.

When was Anjon Bremer Halo System approved by the FDA?

Anjon Bremer Halo System received FDA 510(k) clearance on 2020-03-02, under approval number K193256.

What company makes Anjon Bremer Halo System?

Anjon Bremer Halo System is manufactured by Anjon Holdings, LLC.

What is the FDA product code for Anjon Bremer Halo System?

The FDA product code for Anjon Bremer Halo System is JEC.

Other Devices by Anjon Holdings, LLC

K171863Anjon Bremer Halo System

Related Devices (Code: JEC)

K163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc. K181192PIP FixHand Biomechanics Lab, Inc. K171863Anjon Bremer Halo SystemAnjon Holdings, LLC K192465DigiFix Sterile KitVirak Orthopedics, LLC K203605SteriTrakArbutus Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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