Auxein Nailing System

Screw, Fixation, Bone

Auxein Medical Private Limited

The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Auxein Nailing System.

Pre-market Notification Details

Device IDK210792
510k NumberK210792
Device Name:Auxein Nailing System
ClassificationScrew, Fixation, Bone
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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-08-25

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