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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K213018
Device Name Auxilock GFS Mini, GFS II Large, and GFS Ultimate
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
MBI  
Date Received09/20/2021
Decision Date 11/18/2022
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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