Anjon Bremer Halo System— 510(k) K171863

Substantially Equivalent

Anjon Holdings, LLC

FDA 510(k) clearance K171863 for Anjon Bremer Halo System, Substantially Equivalent on 2018-03-19. Applicant: Anjon Holdings, LLC. Device class: 2.

Clearance details

Applicant: Anjon Holdings, LLC
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2017-06-22
Decision date: 2018-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JEC

K203605 — SteriTrak2021-04-23
K193256 — Anjon Bremer Halo System2020-03-02
K192465 — DigiFix Sterile Kit2019-10-10
K181192 — PIP Fix2018-10-22
K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices2016-12-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.