Auxein Nailing System

Nail, 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 IDK192003
510k NumberK192003
Device Name:Auxein Nailing System
ClassificationNail, Fixation, Bone
Applicant Auxein Medical Private Limited Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial Area Sonepat,  IN 131028
ContactRahul Luthra
CorrespondentRahul Luthra
Auxein Medical Private Limited Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial Area Sonepat,  IN 131028
Product CodeJDS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-26
Decision Date2020-06-10

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