M.U.S.T. Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

MEDACTA INTERNATIONAL SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for M.u.s.t. Pedicle Screw System.

Pre-market Notification Details

Device IDK162061
510k NumberK162061
Device Name:M.U.S.T. Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant MEDACTA INTERNATIONAL SA STRADA REGINA Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentElizabeth Wheeler
MAPI USA, INC 2343 ALEXANDRIA DR, SUITE 100 Lexington,  KY  40504
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-26
Decision Date2016-10-21
Summary:summary

NIH GUDID Devices

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