M.U.S.T. MINI Posterior Cervical Screws System

Posterior Cervical 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. Mini Posterior Cervical Screws System.

Pre-market Notification Details

Device IDK203149
510k NumberK203149
Device Name:M.U.S.T. MINI Posterior Cervical Screws System
ClassificationPosterior Cervical 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 CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-22
Decision Date2020-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971299542 K203149 000
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07630345705891 K203149 000
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07630345705914 K203149 000
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07630345705952 K203149 000
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07630971299566 K203149 000
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07630971299597 K203149 000
07630971299528 K203149 000
07630971299535 K203149 000
07630345705860 K203149 000

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