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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K201427
Device Name Trivergent Spinal Fixation System
Applicant
Benvenue Medical, Inc.
4590 Patrick Henry Dr.
Santa Clara,  CA  95054
Applicant Contact Laurent Schaller
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleston
Regulation Number888.3070
Classification Product Code
NKB  
Date Received05/29/2020
Decision Date 10/21/2020
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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