Mpres Neck Preserving Stem

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

MEDACTA INTERNATIONAL, SA

The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Mpres Neck Preserving Stem.

Pre-market Notification Details

Device IDK210263
510k NumberK210263
Device Name:Mpres Neck Preserving Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant MEDACTA INTERNATIONAL, SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  83118
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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