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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Wedge
510(k) Number K234116
Device Name Trigon Trigon HA Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Analaura Villarreal Berain
Correspondent
Nvision Biomedical Technologies
4590 Lockhill Selma
San Antonio,  TX  78249
Correspondent Contact Analaura Villarreal Berain
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Codes
HRS   HWC  
Date Received12/27/2023
Decision Date 01/26/2024
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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