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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K221787
Device Name Auxein's DHS/DCS Plate System
Applicant
Auxein Medical Private Limited
Plot No. 168,169,170, Phase-IV, Sector 57
Kundli Industrial area
Sonipat,  IN 131028
Applicant Contact Rahul Luthra
Correspondent
Auxein Medical Private Limited
Plot No. 168-169-170, Phase-4,
Kundli Industrial area, HSIIDC, Sector 57
Sonipat,  IN 131028
Correspondent Contact Rahul Luthra
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HRS   HWC   KTW  
Date Received06/21/2022
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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