Trivergent Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Benvenue Medical, Inc.

The following data is part of a premarket notification filed by Benvenue Medical, Inc. with the FDA for Trivergent Spinal Fixation System.

Pre-market Notification Details

Device IDK201427
510k NumberK201427
Device Name:Trivergent Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Benvenue Medical, Inc. 4590 Patrick Henry Dr. Santa Clara,  CA  95054
ContactLaurent Schaller
CorrespondentJustin Eggleston
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2020-10-21

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