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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K210792
Device Name Auxein Nailing 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-IV, Sector 57, Kundli Industrial
Area
Sonipat,  IN 131028
Correspondent Contact Rahul Luthra
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDS  
Date Received03/15/2021
Decision Date 08/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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