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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K213014
Device Name Varixis Elbow 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 Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/20/2021
Decision Date 10/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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