FDA 510(k)

Anjon Bremer Halo System

K-Number: K193256 · 2020-03-02

Decision Date2020-03-02

Product CodeJEC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Anjon Bremer Halo System is the device name listed in this FDA 510(k) record. The listed applicant is Anjon Holdings, LLC. It received FDA 510(k) clearance on 2020-03-02 under 510(k) 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. The listed applicant is Anjon Holdings, LLC. The 510(k) number is K193256.

When did Anjon Bremer Halo System receive FDA 510(k) clearance?

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

Who is the listed applicant for Anjon Bremer Halo System?

The FDA 510(k) record lists Anjon Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Anjon Holdings, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171863Anjon Bremer Halo System

Related Devices (Code: JEC)

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

Official Source

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