Humerus & Ulna System

Plate, 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 Humerus & Ulna System.

Pre-market Notification Details

Device IDK213108
510k NumberK213108
Device Name:Humerus & Ulna System
ClassificationPlate, 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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-24
Decision Date2022-11-04

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