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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 K213059
Device Name Tibia and Fibula System
Applicant
Auxein Medical Private Limited
Plot #168,169,170, Phase-Iv, Sector 57, Kundli Industrial
Area
Sonipat,  IN 131028
Applicant Contact Rahul Luthra
Correspondent
Auxein Medical Private Limited
Plot #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 Received09/22/2021
Decision Date 01/27/2023
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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