Auxilock GFS Mini, GFS II Large, And GFS Ultimate

Fastener, Fixation, Nondegradable, Soft Tissue

Auxein Medical Private Limited

The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Auxilock Gfs Mini, Gfs Ii Large, And Gfs Ultimate.

Pre-market Notification Details

Device IDK213018
510k NumberK213018
Device Name:Auxilock GFS Mini, GFS II Large, And GFS Ultimate
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Auxein Medical Private Limited Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat,  IN 131028
ContactRahul Luthra
CorrespondentRahul Luthra
Auxein Medical Private Limited Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat,  IN 131028
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2022-11-18

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.