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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 K192645
Device Name Trigon™ Ti Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
4754 Shavano Oak, Suite 101
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Watershed Idea Foundry
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Codes
HRS   HWC  
Date Received09/24/2019
Decision Date 12/23/2019
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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