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 IDK193256
510k NumberK193256
Device Name:Anjon Bremer Halo System
ClassificationComponent, Traction, Invasive
Applicant Anjon Holdings LLC 4801 Dawin Road Jacksonville,  FL  32207
ContactKenneth A Collins
CorrespondentKenneth A Collins
Anjon Holdings LLC 4801 Dawin Road Jacksonville,  FL  32207
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-03-02

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