Auxilock Titanium Interference Screw

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 Auxilock Titanium Interference Screw.

Pre-market Notification Details

Device IDK203029
510k NumberK203029
Device Name:Auxilock Titanium Interference Screw
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-02
Decision Date2021-08-20

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