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 IDK193365
510k NumberK193365
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
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630040728805 K193365 000
07630040728799 K193365 000
07630040728782 K193365 000
07630040728775 K193365 000

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