Auxilock Titanium Screw-In Suture Anchor

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 Titanium Screw-in Suture Anchor.

Pre-market Notification Details

Device IDK213104
510k NumberK213104
Device Name:Auxilock Titanium Screw-In Suture Anchor
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 Received2021-09-24
Decision Date2022-07-29

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