MPACT Extension

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mpact Extension.

Pre-market Notification Details

Device IDK200391
510k NumberK200391
Device Name:MPACT Extension
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, 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  38118
Product CodeLPH  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2021-04-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971257566 K200391 000
07630971257467 K200391 000
07630971257474 K200391 000
07630971257481 K200391 000
07630971257498 K200391 000
07630971257504 K200391 000
07630971257511 K200391 000
07630971257528 K200391 000
07630971257535 K200391 000
07630971257542 K200391 000
07630971257559 K200391 000
07630971257450 K200391 000

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